Lilt Bits: Dec 22, 2008

From the recent medical literature...

1. EMS, Emergency Depts Slowly Warm Up to Therapeutic Hypothermia

December 22, 2008 — One of the hottest topics in emergency medicine is a decidedly cold one: therapeutic hypothermia to prevent brain damage in patients after cardiac arrest.

New York City has announced that as of January 1, 2009, emergency medical services (EMS) will take patients who have been resuscitated after cardiac arrest to an emergency department (ED) trained and equipped to perform therapeutic hypothermia, rather than to a closer hospital that does not offer the treatment. Several other US cities, including Boston, Seattle, and Miami, have similar policies in place.

Research Supports NYC Move

In 2002, European and Australian investigators published results of separate studies in which patients who were successfully resuscitated after cardiac arrest caused by ventricular fibrillation were randomly assigned to undergo therapeutic hypothermia to a target temperature of 32° to 34° C or to standard treatment at normal temperatures.

In the European study, 55% of 75 patients treated with mild hypothermia for whom data were available had favorable neurologic outcomes compared with 39% of 137 patients treated according to standard protocols. Six-month overall mortality rates were also lower among patients treated with hyperthermia vs standard care, at 41% vs 55%, respectively. Complication rates were similar between the 2 groups, however (N Engl J Med. 2002;346:549-556).

Similarly, the Australian investigators found that 49% of 43 patients treated with hypothermia after out-of-hospital arrest survived and had a good outcome (discharge home or to rehabilitation) compared with 26% of 34 treated with normothermia. An analysis adjusted for baseline differences in age and time from collapse to the return of spontaneous circulation showed a more than 5-fold greater likelihood for a favorable outcome with hypothermia (N Engl J Med. 2002;346:557-563).

A retrospective study published in 2007 in the journal Resuscitation reported that among 40 consecutive comatose post–cardiac arrest patients with ST-elevation myocardial infarction who received early coronary angiography/percutaneous coronary intervention (PCI) and mild therapeutic hypothermia, the in-hospital mortality rate was 25% compared with 66% for matched historical controls who underwent PCI without therapeutic hypothermia. In all, 78% of patients (21 of 27) treated with hypothermia who survived out to 6 months had a good neurologic outcome compared with only half of control patients (6 of 12 survivors).

Slow Implementation of Hypothermia Programs

Stephan Mayer, MD, chief of the neurological intensive care unit at New York–Presbyterian/Columbia Hospital in New York City and a prominent advocate for NYC's adoption of the new protocol, asks why, if the evidence strongly supports the benefits of hypothermia, aren't more hospitals using it? "What we have is this problem of implementation," Dr. Mayer told Medscape Medical News. "We've known this for 6 years, since the clinical trials, and in addition there have been multiple single-center studies showing bad results with standard care, and when they implemented hypothermia, and have doubled the rate of survival."

Dr. Mayer said that because patients who are comatose after resuscitation have historically had a poor prognosis, there is an assumption by many clinicians that such patients will not benefit from aggressive interventions.

Bret A. Nicks, MD, assistant medical director in the Department of Emergency Medicine at Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina, agrees that the technique has been accepted more slowly than many would like. "Considering that we're 6 years down the road from the clinical trials, most places have not adopted it, because of, number one, the perceived difficulties in starting it, and two, the perceived difficulties in continuing it in the intensive care unit setting," he told Medscape Medical News.

Better Coordination Needed

Dr. Nicks noted that although his center has had a protocol for therapeutic hypothermia in place for several years, "our biggest struggle is that [although] we can continue [ED-initiated hypothermia] in our cardiac intensive care unit, but not all postarrest patients go there; they may go to the medical intensive care unit depending on the nature of their illness, and maintaining that protocol and that concept to keep them cool for neuroprotective properties aren't as well established."

Better coordination of the protocol between the ED and other centers in his institution is a major goal for 2009, he said.

In several large urban centers, including Seattle, Wake County, North Carolina, and Richmond, Virginia, paramedics are trained and equipped for inducing hypothermia in the field. In Richmond, for example, paramedics can initiate cooling during resuscitation, and if the patient has return of spontaneous circulation, the cooling can be continued in transport, with rapid cooling initiated in the ED using a percutaneous catheter technique. The ambulances bypass other hospitals and take all suitable patients directly to Virginia Commonwealth University Medical Center for treatment.

In Wake County, the EMS system in 2006 began prehospital induction of hypothermia for patients with return of spontaneous circulation after cardiac arrest. In the program, all patients aged 16 years and older who are not neurologically intact after resuscitation from nontraumatic arrest are considered for induced cooling in the field, regardless of presenting rhythm. Here too, ambulances transport therapeutic hypothermia candidates directly to 1 of 2 hospitals where cooling can be induced 24 hours a day in the cardiac catheterization lab.

Cardiovascular Benefits of Hypothermia Less Clear

But while the neuroprotective benefits of therapeutic hypothermia are evident, the cardiovascular benefits are not quite as clear, according to Elliott Antman, MD, director of the Samuel A. Levine Cardiac Unit at Brigham & Women's Hospital in Boston, Massachusetts. "That hasn't been as well studied," he told Medscape Medical News. "There are theoretical benefits, but they have not been found to be as compelling as the neurologic benefits. The most important thing from a cardiovascular perspective is the door-to-balloon time."

In a consensus statement published in an advance online edition of Circulation by the International Liaison Committee on Resuscitation (ILCOR), the committee members state that the neuroprotective benefits of hypothermia are well established and that "[t]herapeutic hypothermia should be part of a standardized treatment strategy for comatose survivors of cardiac arrest."

Dr. Nicks said that instituting a therapeutic hypothermia protocol need not be overwhelming — it can be done with cooling blankets and a bear hugger air-cooling device to make a "patient sandwich," plus cool fluids to reach the goal temperatures for mild hypothermia.

"You don't have to go out and buy the expensive central line cooling kit," he said.

But Dr. Mayer noted that low-tech cooling methods are labor intensive, and the methods are less precise than dedicated cooling systems.

"The hours go by and you're not getting the temperatures down where you want them to be, or you're getting them too cold and if the body temperature goes below thirty, you can actually cause ventricular arrhythmia," he pointed out. "The newer technologies work, they're powerful, and the target temperature can be achieved in an hour or two."

Dr. Mayer reports that he is a consultant to Medivance, maker of therapeutic hypothermia equipment, and holds stock in the company. None of the other physicians interviewed have disclosed any relevant financial relationships.

2. Coordination by Hospitalists Eases Emergency Department Crowding

By David Douglas. NEW YORK (Reuters Health) Dec 09 - Active bed management by hospitalists can reduce emergency department (ED) congestion and increase throughput, Maryland-based researchers report in the December 2nd issue of the Annals of Internal Medicine.

"Our study," lead investigator Dr. Eric Howell told Reuters Health, "showed that hospitalists can be part of an effective solution for ED crowding, as well as help solve inpatient hospital capacity issues -- including ICU capacity."

Dr. Howell of Johns Hopkins University School of Medicine, Baltimore, and colleagues explain that the intervention included real-time monitoring of bed availability in ICUs, intermediate care and other units, as well as regular visits to the ED to assess congestion and flow of patients, and to facilitate transfers to appropriate units.

The researchers then compared data from the intervention period (from November 2006 to February 2007) with that from November 2005 to February 2006, prior to the intervention.

During the intervention period there was an 8.8% increase in patients (17,573 versus 16,148). However, throughput for patients who were admitted fell by 98 minutes (360 versus 458 minutes). There was no change in throughput for patients who were not admitted.

The amount of time that ambulances had to be diverted because of ED crowding fell by 6%, and there was a 27% drop in diversion time because of lack of ICU beds.

Dr. Howell concluded that "it is interesting that our study shows that hospitalists can have a dramatic impact on improving quality and efficiency in areas outside of the medical floor -- where hospitalists traditionally care for patients -- like the ED or ICU."

Ann Intern Med 2008;149:804-810. Abstract: http://www.annals.org/cgi/content/abstract/149/11/804

3. Festive Medical Myths

Vreeman RC, Carroll AE. BMJ 2008;337:a2769 [References not included.]

In the pursuit of scientific truth, even widely held medical beliefs require examination or re-examination. Both physicians and non-physicians sometimes believe things about our bodies that just are not true. As a reminder of the need to apply scientific investigation to conventional wisdom, we previously discussed the evidence disputing seven commonly held medical myths.1 The holiday season presents a further opportunity to probe medical beliefs recounted during this time of the year.

We generated a list of common medical or health beliefs related to the holidays and winter season and searched Medline for scientific evidence to support or refute these beliefs. If we couldn’t find any evidence in the medical literature, we searched the internet using Google.

Sugar causes hyperactivity in children
While sugarplums may dance in children’s heads, visions of holiday sweets terrorise parents with anticipation of hyperactive behaviour. Regardless of what parents might believe, however, sugar is not to blame for out of control little ones. At least 12 double blind randomised controlled trials have examined how children react to diets containing different levels of sugar.2 None of these studies, not even studies looking specifically at children with attention-deficit/hyperactivity disorder, could detect any differences in behaviour between the children who had sugar and those who did not.3 This includes sugar from sweets, chocolate, and natural sources. Even in studies of those who were considered "sensitive" to sugar, children did not behave differently after eating sugar full or sugar-free diets.3

Scientists have even studied how parents react to the sugar myth. When parents think their children have been given a drink containing sugar (even if it is really sugar-free), they rate their children’s behaviour as more hyperactive.4 The differences in the children’s behaviour were all in the parents’ minds.4

Suicides increase over the holidays
Holidays can bring out the worst in us. The combined stresses of family dysfunction, exacerbations in loneliness, and more depression over the cold dark winter months are commonly thought to increase the number of suicides. While the holidays might, indeed, be a difficult time for some, there is no good scientific evidence to suggest a holiday peak in suicides.5 6 7

One study from Japan that looked at suicides in 1979-94 showed that the rate of suicide was lowest in the days before a holiday and highest in the days after the holiday.8 In contrast, in a study from the United States of suicides over a 35 year period, there was no increase before, during, or after holidays.9 Indeed, people might actually experience increased emotional and social support during holidays. In the US, rates of psychiatric visits decrease before Christmas and increase again afterwards.10 A smaller study of adolescents showed a peak in suicide attempts at the end of the school year,11 possibly reflecting a decrease in social support. Data from Ireland on suicide in 1990-8 also failed to connect suicides with the holidays.12 While Irish women were no more likely to commit suicide on holidays than on any other days, Irish men were actually significantly less likely to do so.

Further debunking myths about suicide, people are not more likely to commit suicide during the dark winter months. Around the world, suicides peak in warmer months and are actually lowest in the winter. In Finland, suicides peak in autumn and are lowest in the winter.13 In a 30 year study of suicides in Hungary, researchers again found the highest rates of suicides in the summer and the lowest in the winter.14 Studies of suicide rates from India also show peaks in April and May.15 Studies from the US reflect this pattern, with lower rates in November and December than in typically warmer months.6

Of course, none of this evidence suggests that suicides do not happen over the holidays. The epidemiological evidence just does not support that the holidays are a time of increased risk.

Poinsettia toxicity
With flowers and leaves of red, green, and white, poinsettias are widely used in holiday decorations. Even though public health officials have reported that poinsettias are safe, many continue to believe this is a poisonous plant.16

In an analysis of 849 575 plant exposures reported to the American Association of Poison Control Centers,17 none of the 22 793 cases involving poinsettia resulted in considerable poisoning.17 No one died from exposure to or ingestion of poinsettia, and most (96%) did not even require medical treatment. In 92 of the cases, children ingested substantial quantities of poinsettias, but none needed medical treatment, and toxicologists concluded that poinsettia exposures and ingestions can be treated without referral to a healthcare facility.17 Another study, looking at poinsettia ingestion by rats, could not find a toxic amount of poinsettia, even at amounts that would be the equivalent of 500-600 poinsettia leaves or nearly a kilogram of sap.18

Excess heat loss in the hatless
As temperatures drop, hats and caps flourish. Even the US Army Field manual for survival recommends covering your head in cold weather because "40 to 45 percent of body heat" is lost through the head.19 If this were true, humans would be just as cold if they went without trousers as if they went without a hat. But patently this is just not the case.

This myth probably originated with an old military study in which scientists put subjects in arctic survival suits (but no hats) and measured their heat loss in extremely cold temperatures.20 Because it was the only part of the subjects’ bodies that was exposed to the cold, they lost the most heat through their heads. Experts say, however, that had this experiment been performed with subjects wearing only swimsuits, they would not have lost more than 10% of their body heat through their heads.20 A more recent study confirms that there is nothing special about the head and heat loss.21 Any uncovered part of the body loses heat and will reduce the core body temperature proportionally. So, if it is cold outside, you should protect your body. But whether you want to keep your head covered or not is up to you.

Nocturnal feasting makes you fat
Holiday feasts and festivities present us with many culinary options. A common suggestion to avoid unwanted weight gain is to avoid eating at night, and at first glance, some scientific studies seem to support this. In a study of 83 obese and 94 non-obese women in Sweden, the obese women reported eating more meals, and their meals were shifted to the afternoon, evening, or night.22 But just because obesity and eating more meals at night are associated, it does not mean that one causes the other. People gain weight because they take in more calories overall than they burn up. The obese women were not just night eaters, they were also eating more meals, and taking in more calories makes you gain weight regardless of when calories are consumed.

Other studies found no link at all between eating at night and weight gain. Swedish men did not show any evidence of gaining weight with night time meals.23 In a study of 86 obese and 61 normal weight men, there were no differences in the timing of when they ate.23 Another study of 15 obese people found that the timing of meals did not change the circadian rhythm pattern of energy expenditure.24 In a study of over 2500 patients, eating at night was not associated with weight gain, but eating more than three times a day was linked to being overweight or obese.25 Studies have connected skipping breakfast with gaining more weight, but this is not because breakfast skippers eat more at night.26 Breakfast skippers eat more during the rest of the day. Records of calorie intake suggest that those who eat breakfast maintain healthy weights because their calorie intake is more evenly distributed over the day.26 27 In other words, when you eat three regular meals, you are not as likely to overeat at any one particular meal or time.

You can cure a hangover
From aspirin and bananas to Vegemite and water, internet searches present seemingly endless options for preventing or treating alcohol hangovers.28 Even medical experts offer suggestions.29

No scientific evidence, however, supports any cure or effective prevention for alcohol hangovers. A systematic review of randomised trials evaluating medical interventions for preventing or treating hangovers found no effective interventions in either traditional or complementary medicine.28 While a few small studies using unvalidated symptom scores showed minor improvements, the conclusion of the exhaustive review was that propranolol, tropisetron, tolfenamic acid, fructose or glucose, and dietary supplements including borage, artichoke, prickly pear, and Vegemite all failed to effectively "cure hangovers." While more recent studies in rats show some potential for new products to alter mechanisms associated with hangovers,30 31 humans also face risks when using certain "hangover cures."32 A hangover is caused by excess alcohol consumption. Thus, the most effective way to avoid a hangover is to consume alcohol only in moderation or not at all.

Conclusions
Examining common medical myths reminds us to be aware of when evidence supports our advice, and when we operate based on unexamined beliefs. This was not a systematic review of either the evidence to refute these medical myths or of doctors’ beliefs. None the less, we applied rigorous search methods to compile data, and evidence of the prevalence of these medical beliefs is readily available. Only by investigation, discussion, and debate can we reveal the existence of such myths and move the field of medicine forward.

4. Women with STEMI Fare Worse Than Men

Lisa Nainggolan. From Heartwire — a professional news service of WebMD. December 10, 2008 — A contemporary look at whether there are still differences between men and women in terms of medical care and outcomes after acute myocardial infarction (AMI) has revealed that the situation appears to be improving for women but that there is still some way to go to achieve equality [1].

In their report published online December 8, 2008 in Circulation, Dr Hani Jneid (Baylor College of Medicine and Michael E De Bakey VA Medical Center, Houston, TX) and colleagues analyzed data from the American Heart Association (AHA) Get With the Guidelines program and found no differences between the sexes in terms of in-hospital mortality from AMI. However, women with ST-elevation MI (STEMI) were still more likely than men to die in the hospital.

Our work is still cut out for us
"It's disturbing that there is still a persistent gap in mortality in the highest-risk STEMI group," Jneid told heartwire. "We were able to close the gap between the sexes after adjusting for age and risk factors, but we found a disparity across the board in all treatments between women and men and a disturbing delay in treatment in women compared with men. We have room to improve on the healthcare and outcome of women when they present with this severe type of heart attack."

Dr Nieca Goldberg (Women's Heart Center, New York University, NY), an AHA spokesperson who was not involved in the research but has a special interest in women's health, told heartwire: "I'm disappointed by this research, as there have been a lot of campaigns to increase awareness about cardiovascular disease in women. It seems like we've improved our care in women with non-STEMI, but it's kind of confusing to me why women with a STEMI come in and are more likely to die." She adds that she is reassured that doctors seem to have gotten better at treating the subtler forms of heart attack, "but our work is still cut out for us."

Women less likely to receive adequate therapies

In their study, Jneid et al examined sex differences in care processes and in-hospital deaths among 78,254 patients with AMI in 420 US hospitals from 2001 to 2006. Women, in general, were older, had more comorbidities, less often presented with STEMI, and had higher unadjusted in-hospital death (8.2% vs 5.7% for men; p less than 0.0001).

But after multivariate adjustment, sex differences in in-hospital mortality were no longer apparent in the overall AMI cohort (adjusted odds ratio 1.04), although they persisted among STEMI patients (mortality rate 10.2% among women compared with 5.5% in men; p less than 0.0001; adjusted odds ratio [OR] 1.12).

This excess death seen in women with STEMI was primarily accounted for by an excess of very early deaths among women in the initial 24 hours of hospitalization, the researchers note. Women were less likely to receive early medical treatments, acute reperfusion therapies, timely pharmacological and mechanical reperfusion, and invasive procedures.

"This tells us that there are true disparities," Jneid says.

Abstract: http://circ.ahajournals.org/cgi/content/abstract/CIRCULATIONAHA.108.789800v1

5. No Benefit of TNK in Cardiac Arrest: TROICA Published

from Heartwire — a professional news service of WebMD. December 19, 2008 — The first large-scale trial to investigate the addition of the thrombolytic tenecteplase (TNK) to standard cardiopulmonary resuscitation (CPR) — which showed no increase in survival in cardiac-arrest patients given such therapy — has been published in the December 19, 2008, issue of the New England Journal of Medicine. The results were first presented at the World Congress of Cardiology in Barcelona two years ago, as reported by heartwire.

Lead author Dr Bernd Boettiger (University of Cologne, Germany), who also presented the study — called Thrombolysis in Cardiac Arrest (TROICA) — in Barcelona, told heartwire that nothing has changed between the presentation and publication, except for the fact that the survival rates reported in Barcelona were slightly higher, because asystolic patients were excluded from the analysis. "The New England Journal of Medicine recommended that we include the asystolic patients (n = 209), so we have a slightly lower survival rate in the paper by incorporating these patients with a very poor prognosis," he remarked.

Nevertheless, the overall conclusion is the same, he says. "In the setting of witnessed cardiac arrest of presumed cardiac origin, there is no additional benefit from the use of TNK without concomitant antithrombotic treatment. This was a result that was very disappointing to us, as we did expect it would help very much."

But as he stressed in Barcelona, Boettiger is not yet ready to give up on this strategy completely. "Further investigation has to focus on combining TNK treatment with anticoagulants, such as heparin, and other things. We are working on further trials because we are convinced that anticoagulation plays a role in reperfusion after cardiac arrest, and we have been discussing with industry as to how we can proceed from here."

Boettiger BW, Arntz HR, Chamberlain DA, et al. Thrombolysis during resuscitation for out-of-hospital cardiac arrest. N Engl J Med. 2008;359:2651-2662. Abstract: http://content.nejm.org/cgi/content/abstract/359/25/2651

6. Inhaled corticosteroids don’t reduce mortality in stable COPD

JAMA 2008;300:2407-16.

Like most drug treatments for chronic obstructive pulmonary disease (COPD), inhaled corticosteroids are better at symptom control and preventing exacerbations than they are at saving lives. The latest meta-analysis to look specifically at mortality found that long term inhaled steroids made no difference to survival for people with stable disease but did increase the risk of pneumonia.

The authors found 11 randomised trials evaluating fluticasone, triamcinolone, and budesonide, alone or in combination with other inhaled drugs, usually salmeterol. The trials tested treatments that lasted at least six months and studied more than 14 000 adults between them. Relative risk of death was 0.86 (95% CI 0.68 to 1.09) in patients treated with inhaled steroids, compared with controls given placebo or other inhaled drugs. Subgroup analyses looking at the effect of duration of treatment, type of product (monotherapy or combined), severity of disease, and dose were all negative. Inhaled corticosteroids were associated with a significant 34% increase in the risk of pneumonia (1.34, 1.03 to 1.75), but no extra fractures (1.09, 0.89 to 1.33).

Because this treatment seems to have no effect on mortality, doctors must weigh up the other risks (pneumonia) and benefits (fewer exacerbations, improved quality of life) when making therapeutic decisions in patients with stable chronic pulmonary obstructive disease, say the authors. As usual, the balance will vary between different subgroups. In this analysis, risk of pneumonia was highest in patients with the poorest lung function, those given higher doses, and those treated with combined products. Doctors who decide to prescribe inhaled steroids should use the lowest effective dose, say the authors.

7. They Don’t Train ’em Like They Used to

Taylor JS, et al. BMJ 2008;337:a2895. [Tables not included.]

To check perceptions that the younger generation are lacking the etiquette of their seniors, we reviewed over 300 radiology request forms written on a single weekday in a hospital on the south coast of England. We used the presence of the word "please" on the request form as a proxy measure of courtesy (table 1).

Table 1. Use of "please" on radiology request forms

Consultants and associate specialists came out on top. Junior hospital doctors (all grades) did less well, although better than nurses. Overall, the staff in the intensive therapy unit and the accident and emergency department scored modestly.

Among consultants, those in general surgery and general medicine were the most courteous, and orthopaedic surgeons conformed to their alledged stereotype of never requesting politely. However, the results for orthopaedic juniors give faint grounds for hope.

Graduates of Birmingham, Bristol, and Nottingham medical schools seemed the most polite, although the numbers are small (table 2). Foundation year docotors’ results were variable, with notable politeness from St George’s Medical School. Senior trainees from Guy’s, King’s and St Thomas’ and from Cambridge also scored very well.

Table 2. Use of "please" on radiology request forms, by medical school

Our investigation shows that seniors still set the gold standard for chivalry, with the rest of us only hoping to emulate them.

8. The fattening truth about restaurant food

Karen McColl. BMJ 2008;337:a2229

Going out to eat is often a disaster for the waistline. Karen McColl reports on US efforts to make diners more aware of what they are eating

Customers going into restaurant chains like Burger King or Starbucks in New York can now take calories into account when they choose what to eat. Since May, chain restaurants in the city have been required to include calorie contents on menu boards, menus, and item tags. The law applies to restaurant chains with more than 15 branches nationally.

Similar menu labelling, or "calorie posting," laws came into force in September in San Francisco and Santa Clara County in California, and the requirement will soon apply to the whole state. Arnold Schwarzenegger has now approved an amended version of a menu labelling bill that he vetoed last year, making California the first state to pass a menu labelling law. Around 20 cities and states across the US are considering menu labelling legislation. But the restaurant industry is fighting all the way.

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"It’s just the most astonishing thing I’ve ever seen," says Marion Nestle from New York University. Professor Nestle is an academic nutritionist with decades of experience advising on nutrition issues. Yet, since calories have been posted on menus in New York she has been surprised. "For someone like me who thinks that they know about these things, I’m stunned by the number of calories in fast foods. I had no idea." As examples, she cites a blueberry and pomegranate smoothie that provides 1180 kcal (4.9 MJ) and a pizza for one person with more than 2000 kcal (8.3 MJ).

Professor Nestle is not the only nutrition expert to have difficulty assessing the nutritional content of fast food. The Food Commission recently asked 66 nutrition experts at an international obesity conference whether they could tell from the menu description which food was likely to contain most energy or fat. None of the experts answered all five questions correctly, and only a quarter answered more than two questions correctly.

Given that nutrition experts have difficulty choosing the healthiest options, what hope for the rest of the population? Research shows that consumers, like nutrition experts, have difficulty assessing the calorie content of fast food items and that people tend to underestimate energy content.

It is because people find it difficult to estimate calories that these laws are being introduced as part of an effort to tackle obesity, which now affects a third of US adults. Another key factor is the importance of eating out in the overall diet. Americans consume around one third of their calories outside the home, and nearly three quarters of all restaurant visits are to fast food or other chain restaurants. A survey of over 7000 fast food customers by New York’s health department found that a third (34%) of respondents purchased 1000 kilocalories or more at lunchtime.6 Research also shows that when calorie information is given people tend to choose high calorie items less often.6 7 We also know that consumers—both in the US and the UK—strongly favour having more accessible nutrition information when they eat out.

"We’re confident that this law will have two positive effects," says Tom Frieden, New York’s health commissioner. "The first is to encourage restaurants to offer healthier options, and the second will be to encourage some customers to make healthier choices." Dr Frieden estimates that the legislation could result in 150 000 fewer New Yorkers being obese and 30 000 fewer cases of diabetes in the city over the next five years.

Improved visibility
Although many fast food chains already make nutrition information available, few customers see this information. At the time of the New York survey only Subway provided information at the point of purchase. Among customers of other outlets, just 4% reported seeing calorie information. Some nutrition information is available on company websites. Calculations based on figures from McDonald’s, which now also provides nutrition information on the back of tray liners, show that its nutrition information website receives one hit for every 25 000 meals sold. Where restaurants provide nutrition information leaflets on site, public health advocates argue that this information is overly complex and is not readily accessible when consumers order their food.

The key concept behind the menu labelling rules is to provide information in places where people will see it when they are choosing what to order. That means on menu boards and menus. Fast food restaurants describe the menu board as their most important means of communicating with customers, and this is one of the reasons that they have been resisting the legislation so strongly.

Although it is still too early to evaluate the impact of the new law, newspaper and blogs have been full of reports quoting shocked customers. Dr Frieden says that preliminary feedback suggests consumers are becoming more aware of calories, and some outlets are also starting to change what is on offer. There are reports of leading chains highlighting lower calorie options on the menus and introducing healthier options.

"What you hear essentially is sticker shock about the number of [kilo]calories in some common items—whether it’s a 600 calorie cup of coffee, a 1200 calorie salad, a 1400 calorie breakfast, or a 2700 calorie appetiser," Dr Frieden says.

Professor Nestle agrees that some New Yorkers are in shock, but is concerned that the numbers mean little to people who do not know that a typical adult needs only around 2000 kilocalories a day. "It’s a good thing, but it needs to be accompanied by a very clear know your number message so that you know that you should be aiming to consume somewhere in the 2000 range every day," she said. The California legislation does require restaurants to include information explaining recommended intakes in nutrition leaflets. In October the New York Health Department launched an advertising campaign to get the message across that most adults need no more than 2000 kilocalories a day to maintain a healthy weight. Dr Frieden also points out that even if you don’t know how many calories you should be consuming in a day, you can still use the calorie information to compare items and make healthier choices.

Industry response
The restaurant industry has been vigorously opposing the menu labelling legislation. The New York State Restaurant Association has challenged the legislation in court, arguing that the regulation overlaps with federal law and violates their members’ free speech by compelling them to deliver a government message about the importance of calories. The court rejected both arguments in April. The association has appealed, and the appeal court’s decision is expected any day now. In the meantime, restaurants have to comply with the legislation.

In Seattle (King County), industry lobbying and pressure from the state legislature obtained a compromise that allows calories to be posted on signs next to menu boards or on eye level signs at the point of ordering instead of menu boards.

As well as using the legal systems to get menu labelling revoked, the restaurant industry is lobbying for legislation to ban such laws being passed in the first place. Ohio and Georgia have recently passed state measures that prohibit any local authorities from introducing menu labelling legislation. There are signs that some restaurant chains now accept that these rules are here to stay. Yum brands, which owns the Pizza Hut and KFC chains, announced on 1 October that it will introduce calorie counts on menu boards in its 20 000 US outlets by 2011.

9. GASP! Agonal Breathing Common, Predicts Survival After Out-of-Hospital Cardiac Arrest

from Heartwire — a professional news service of WebMD. Steve Stiles. November 27, 2008 (Tucson, AZ) - Someone stricken with out-of-hospital cardiac arrest might still be gasping for air, but that's no reason for witnesses to avoid jumping in with chest compressions, according to researchers who studied the phenomenon [1]. On the contrary, that initial period of distressed breathing might last only minutes but provides the best chance for resuscitation efforts to succeed and allow the patient to survive to hospital discharge, suggests a retrospective analysis published online November 24, 2008 in Circulation.

About a third of more than 1200 cases of witnessed out-of-hospital cardiac arrest attended by Arizona emergency medical services (EMS) over a recent three-year period were characterized by gasping, "often referred to as snoring, snorting, gurgling, or moaning, or as agonal, barely, labored, noisy, or heavy breathing," report the authors, led by Dr Bentley J Bobrow (Mayo Clinic College of Medicine, Phoenix, AZ, and University of Arizona Sarver Heart Center, Tucson). Gasping was most frequent in the early minutes after the patients collapsed.

The patients who gasped, compared with those who didn't, were overall three times more likely to survive to hospital discharge, but were five times more likely if they received bystander cardiopulmonary resuscitation (CPR).

Gasping is an indication that you're doing a great job and you shouldn’t stop.

The incidence and prognostic implications of gasping at cardiac arrest are underappreciated, a shortfall in public education that can delay or discourage bystander participation, according to Bobrow et al. "It is not uncommon to hear anecdotal reports that bystanders (even medical professionals) failed to initiate CPR because they concluded that the patient was still breathing and therefore did not have a cardiac arrest," they write. (Their study, however, does not show this.)

The gasping is a sign of poor but marginally adequate cerebral perfusion, and it is promising whether it starts as the patient collapses or only after the beginning of CPR, according to coauthor Dr Gordon A Ewy (University of Arizona Sarver Heart Center). Lay people who initiate CPR tend to be startled if gasping occurs, believing the patient is "waking up," and then often stop what they are doing, he said to heartwire. But, "gasping is an indication that you're doing a great job and you shouldn’t stop."

In a review of records from the Phoenix Fire Department Regional Dispatch Center, the authors observed that 44 of 113 cases (39%) of witnessed and unwitnessed out-of-hospital cardiac arrests were characterized by abnormal breathing.

They looked at the phenomenon's prevalence in relation to EMS response times for 1218 cases of witnessed out-of-hospital cardiac arrest occurring in Arizona from 2004 to 2007. Whether EMS personnel observed gasping was inversely related to how soon they arrived after the patient's collapse.

Gasping was associated with a significantly increased odds of survival to hospital discharge, the study's primary end point--whether or not, but especially if, bystander CPR was performed.

Gasping was observed by EMS personnel in 33% of cases when collapse occurred with EMS on the scene, and the rate steadily decreased with EMS arrival times: 20% for less than 7 minutes, 14% for 7 to 9 minutes, and 7.5% for more than 9 minutes. The odds ratio for gasping with EMS arrival beyond 9 minutes after collapse was 0.30, compared with less than 7 minutes (p less than 0.001) after adjustment for age, sex, whether bystander CPR was performed, location of cardiac arrest, and whether VF was documented.

Ewy is among the principal advocates of what he calls cardiocerebral resuscitation for arrest of cardiac origin, characterized most notably by an emphasis on chest compressions uninterrupted by assisted breathing. The technique, as previously reported by heartwire, was recently endorsed by the American Heart Association as being about as effective as the traditional method involving compressions plus "mouth to mouth" resuscitation.

But proponents of the chest-compression-only method say it is superior, not only in being more successful but in encouraging bystanders to attempt it in the first place. In fact, Ewy said, the current study was designed, in part, to help get the public and providers to see abnormal breathing as a reason to initiate or continue CPR rather than a reason to stop or avoid it.

Ewy has no industry-related disclosures; of his coauthors, Dr Robert A Berg (University of Arizona Sarver Heart Center) discloses grant support from Medtronic and Dr Karl B Kern (University of Arizona Sarver Heart Center) reports being on the scientific advisory committees of Zoll and PhysioControl.

Abstract: http://circ.ahajournals.org/cgi/content/abstract/CIRCULATIONAHA.108.799940v1

10. Health, Emergency Staff Get Drugs First in Pandemic

WASHINGTON (Reuters) Dec 17 - Health care and emergency services workers who might help sick people during an influenza pandemic should take antiviral drugs throughout the epidemic, the U.S. Department of Health and Human Services said in new guidance released on Tuesday.

Employers such as hospitals should be responsible for stockpiling the drugs and designating who gets them, HHS said in its latest guidance.

People with weakened immune systems, such as cancer patients, should also get so-called prophylactic antivirals, which means taking them before they ever get sick, HHS said.

Two antiviral drugs can both prevent and treat all forms of influenza A, including H5N1. They are Roche and Gilead Sciences Inc's Tamiflu and GlaxoSmithKline and Biota Holdings Ltd's Relenza.

"Planning and preparing for a pandemic influenza requires action by every part of society, including individuals and families, communities, and private sector employers as well as all levels of government," Dr. Craig Vanderwagen, HHS assistant secretary for preparedness and response, said in a statement.

"Employers will play a key role in protecting employees' health and safety, which in turn reduces the impact of a pandemic on the nation's health, the economy and society."

HHS earlier encouraged employers to stockpile the drugs, which can both treat and prevent flu.

In July, HHS said about a million essential health care workers would be immunized first if a flu pandemic broke out in the United States.

Many public health experts agree some sort of influenza pandemic is inevitable, although no one can predict when it might come and how severe it may be.

It is also impossible to predict what strain of flu might cause it, although H5N1 avian influenza is the main suspect now. It has become entrenched in birds in Asia, Europe, the Middle East and possibly Africa.

While just 390 people have been infected since 2003 and 246 have died, experts fear H5N1 could acquire the ability to spread easily from human to human, setting off a pandemic that could kill hundreds of millions of people.

11. Head and neck injury risks in heavy metal: head bangers stuck between rock and a hard bass

Patton D, et al. BMJ 2008;337:a2825

Objective: To investigate the risks of mild traumatic brain injury and neck injury associated with head banging, a popular dance form accompanying heavy metal music.
Design Observational studies, focus group, and biomechanical analysis.

Participants: Head bangers.

Main outcome measures: Head Injury Criterion and Neck Injury Criterion were derived for head banging styles and both popular heavy metal songs and easy listening music controls.

Results: An average head banging song has a tempo of about 146 beats per minute, which is predicted to cause mild head injury when the range of motion is greater than 75°. At higher tempos and greater ranges of motion there is a risk of neck injury.

Conclusion: To minimise the risk of head and neck injury, head bangers should decrease their range of head and neck motion, head bang to slower tempo songs by replacing heavy metal with adult oriented rock, only head bang to every second beat, or use personal protective equipment.

12. Safety Improvements Mandated for Emergency Dept Design, Management

Laurie Barclay, MD. December 9, 2008 — Safety improvements in emergency department (ED) design and management are needed, according to a survey of emergency department clinicians reported in the December 5 issue of the Annals of Emergency Medicine.

"This is a national problem," lead author David Magid, MD, senior scientist at the Kaiser Permanente Colorado Institute for Health Research and director for research at the Colorado Permanente Medical Group in Denver, said in a news release. "It doesn't matter if the hospital is big or small, an academic or community-based institution, or the region of the country."

The study objective was to evaluate the degree to which EDs are designed, managed, and supported in ways that promote patient safety.

"A basic tenet of quality and safety theory is that personnel involved in daily work are often best informed to identify problems that threaten quality and safety in the workplace," the study authors write. "According to previous work on the state of US EDs and the prevalence of safety problems in EDs, we hypothesized that reports of ED personnel would reveal multiple opportunities to improve ED systems in ways that might contribute to safety of care."

Clinicians working in 65 US EDs completed a validated, psychometrically tested survey evaluating their observations and opinions regarding the EDs' physical environment, staffing, equipment and supplies, nursing, teamwork, safety culture, triage and monitoring, and coordination of information flow, consultation, and flow to inpatient departments.

Response rate was 66%, with 3562 eligible respondents completing the survey. The participants often reported problems in 4 systems vital to ED safety: physical environment, staffing, inpatient coordination, and information coordination and consultation. Across all 9 domains surveyed, few respondents reported that support systems were adequate most or all of the time.

Space was reported to be inadequate for the delivery of care most (25%) or some (37%) of the time. In addition, clinicians reported that the number of patients exceeded ED capacity to ensure safe care most (32%) or some (50%) of the time.

Only 41% of respondents reported that most of the time, specialty consultation for critically ill patients arrived within 30 minutes of being contacted, and half reported that ED patients needing intensive care unit admission were rarely transferred from the ED to the intensive care unit within 1 hour.

About 40% of respondents reported that physician staffing is inadequate to handle patient loads during busy periods, two thirds reported that nursing staff is insufficient to handle patient loads during busy periods, and one third reported that patients in the ED's waiting rooms are monitored often.

"Reports by ED clinicians suggest that substantial improvements in institutional design, management, and support for emergency care are necessary to maximize patient safety in US EDs," the study authors write. "Our results suggest that conditions may be somewhat better in smaller, non–residency-affiliated EDs."

Study limitations include lack of generalizability to all US EDs, reliance on clinician report rather than direct observation of the conditions being investigated, and an inability to determine whether perceived deficiencies were actually associated with hazard or harm to patients.

Factors that may hinder provision of safe ED care may include loss of information during handoffs at change of shift and frequent interruptions of ED clinicians.

"Gaining access to a patient's medical record is often difficult, and the availability of computers in the ED is frequently inadequate," the study authors conclude. "Finally, with respect to safety culture, the blaming of individuals for safety problems remains common, and hospital administrators are frequently perceived not to be supportive of improving patient safety.

This study was supported by the Agency for Healthcare Research and Quality.

Ann Emerg Med. Published online December 5, 2008. Abstract: http://www.annemergmed.com/article/S0196-0644(08)01863-5/abstract

13. In Upper GI Bleeding, Choosing Who Gets Admitted and Who Goes Home

A scoring system based on simple clinical evaluation and without the need for endoscopy can identify low-risk patients who present with upper gastrointestinal bleeding, according to a Lancet study released online.

Researchers compared two scoring systems for predicting level of risk in patients presenting with upper GI hemorrhage to four U.K. hospitals — the widely used Rockall score and the newer Glasgow-Blatchford bleeding score (GBS). (The GBS is based on lab values — namely, blood urea and hemoglobin — along with systolic pressure, pulse, and presenting signs. Patients with normal values and no melena, syncope, or evidence of liver disease or heart failure are considered to be at low risk and thus eligible for outpatient management.)

The GBS outperformed the Rockall score at identifying low-risk patients in the emergency room, resulting in fewer hospitalizations. None of the patients with low-risk GBS required intervention for hemorrhage or had died after at least 6 months' follow-up.
The Lancet. Published online December 15, 2008.

14. Epidemic of Overdose Deaths Linked to Nonmedical Use of Prescription Opioids

December 11, 2008 — Up to 93% of unintentional overdose deaths in West Virginia, 1 of the poorest US states, are due to nonmedical use of prescription pharmaceuticals, primarily opioid analgesics, new research shows.

A population-based, observational study by investigators at the Centers for Disease Control and Prevention (CDC), in Atlanta, Georgia, shows nearly two-thirds of all drug-overdose deaths involved prescription diversion, meaning those who died did not have prescriptions for the drugs that killed them.

"We had anticipated that drug diversion would be an important contributor to these [overdose] deaths. However, the finding that nearly two-thirds of the deaths involved prescription drug diversion was particularly noteworthy," principal investigator Aron J. Hall, DVM, told Medscape Psychiatry.

Furthermore, investigators found that "doctor shopping" was a major contributor to unintentional drug-overdose mortality. "Roughly 1 in 5 of those who died had evidence of doctor shopping, which was defined as an individual who had 5 or more health providers in the previous year writing prescriptions for controlled substances," he said.

Hall AJ, et al. JAMA. 2008;300:2613-2620. Abstract: http://jama.ama-assn.org/cgi/content/abstract/300/22/2613

15. Internet-Based CME Leads to Good Evidence-Based Clinical Choices

NEW YORK (Reuters Health) Dec 10 - Physicians who participate in selected internet-based continuing medical education (CME) activities are more likely to make evidence-based clinical decisions than their counterparts who do not participate in these types of CME, according to new research.

Linda Casebeer of Outcomes, Inc., in Birmingham, Alabama, and colleagues with Medscape, LLC, of New York, Harvard Medical School in Boston, and the University of Alabama at Birmingham, conducted a controlled trial of the effectiveness of 48 internet-based CME activities.

Responses to several case vignettes reflecting the information provided in the CME activities were assessed for 2785 physicians who participated in the CME programs and 2836 nonparticipants.

There was a 45% increased likelihood that participants made clinical decisions in various vignettes based on clinical evidence, Casebeer and colleagues report in BioMed Central (BMC) Medicine, issued online December 4.

"This likelihood was higher in interactive case-based activities, 51%, than for text-based clinical updates, 40%," the team found. Effectiveness was higher among primary care physicians than specialists, the authors add.

"Internet CME activities show promise in offering a searchable, credible, available on-demand, high-impact source of CME for physicians," Casebeer and colleagues conclude.

BMC Medicine 2008;6. Abstract: http://www.biomedcentral.com/1741-7015/6/37/abstract

16. Thrombolytic Therapy: Not for Uncomplicated PE

Patients without hemodynamic compromise had higher mortality rates when they were given thrombolytic therapy.

Ibrahim SA, et al. Arch Intern Med. 2008;168:2183-2190. Abstract: http://archinte.ama-assn.org/cgi/content/abstract/168/20/2183

Editorial: Systemic thrombolysis effectively and rapidly dissolves clots in the pulmonary vasculature as well as the deep veins, but unlike thrombi in coronary or cerebral arteries, a PE usually does not result in permanent tissue necrosis. Provided that the patient survives the immediate hemodynamic effects of the initial event, therapy with antithrombotics alone (heparin products followed by warfarin) will usually keep further clotting at bay, allowing the body's natural fibrinolytic system to slowly dissolve any existing thromboses. This favorable response to standard anticoagulation in the majority of patients with PE, coupled with the known hemorrhagic risks of systemic thrombolysis, limits the target population for thrombolysis to those patients at high risk for hemodynamic collapse…

Brotman DJ, et al. Arch Intern Med. 2008;168:2191-2192.

17. Ultrasound in the ED Diagnosis of CHF

Identification of congestive heart failure via respiratory variation of inferior vena cava diameter

Blehar DJ, et al. Amer J Emerg Med. 2009;27:71-75.

Introduction
Rapid diagnosis of volume overload in patients with suspected congestive heart failure (CHF) is necessary for the timely administration of therapeutic agents. We sought to use the measurement of respiratory variation of inferior vena cava (IVC) diameter as a diagnostic tool for identification of CHF in patients presenting with acute dyspnea.

Methods
The IVC was measured sonographically during a complete respiratory cycle of 46 patients meeting study criteria. Percentage of respiratory variation of IVC diameter was compared to the diagnosis of CHF or alternative diagnosis.

Results
Respiratory variation of IVC was smaller in patients with CHF (9.6%) than without CHF (46%) and showed good diagnostic accuracy with area under the receiver operating characteristic curve of 0.96. Receiver operating characteristic curve analysis showed optimum cutoff of 15% variation or less of IVC diameter with 92% sensitivity and 84% specificity for the diagnosis of CHF.

Conclusion
Inferior vena cava ultrasound is a rapid, reliable means for identification of CHF in the acutely dyspneic patient.

18. A worrying proportion of the British medical students can’t tell their left from their right

Gormley GJ, et al. BMJ 2008;337:a2826

Right-left discrimination among medical students: questionnaire and psychometric study

Objective: To determine medical students’ self awareness and ability to discriminate right from left; to identify characteristics associated with this ability; and to identify any techniques used to aid discrimination.

Design: Questionnaire and psychometric study.

Setting: Undergraduate medical school, Northern Ireland.

Participants: 290 first year undergraduate students.

Main outcome measure: Medical students’ ability to discriminate right from left using the Bergen right-left discrimination test.

Results: Test scores ranged from 31 to 143 on a scale of 0-144 (mean 112 (standard deviation 22.2)). Male students significantly outperformed female students (117.18 (26.96) v 110.80 (28.94)). Students who wanted to be surgeons performed significantly better than those who wanted to be general practitioners or medical doctors (119.87 (25.15) v 110.55 (27.36) v 112.50 (26.88)). The interaction effect for sex and career wishes was not significant (P=0.370). Students who used learnt techniques to help them discriminate scored significantly less than those who did not (P less than 0.001). Students had greater difficulty in discriminating right from left when looking at the forward view rather than the back view (P less than 0.001).

Conclusions: Male students were better than female students at distinguishing right from left, and aspiring surgeons were better than aspiring general practitioners or medical doctors. Students had more difficulty with the forward view than the back view.

19. Use of lipid emulsion in the resuscitation of patients overdosing on lipid-soluble drugs

Sirianni AJ. Ann Emerg Med. 2008;51:412-5, 415.e1.

Animal studies show efficacy of intravenous lipid emulsion in the treatment of severe cardiotoxicity associated with local anesthetics, clomipramine, and verapamil, possibly by trapping such lipophilic drugs in an expanded plasma lipid compartment ("lipid sink"). Recent case reports describe lipid infusion for the successful treatment of refractory cardiac arrest caused by parenteral administration of local anesthetics, but clinical evidence has been lacking for lipid's antidotal efficacy on toxicity caused by ingested medications.

A 17-year-old girl developed seizure activity and cardiovascular collapse after intentional ingestion of up to 7.95 g of bupropion and 4 g of lamotrigine. Standard cardiopulmonary resuscitation for 70 minutes was unsuccessful in restoring sustained circulation. A 100-mL intravenous bolus of 20% lipid emulsion was then administered, and after 1 minute an effective sustained pulse was observed. The patient subsequently manifested significant acute lung injury but had rapid improvement in cardiovascular status and recovered, with near-normal neurologic function. Serum bupropion levels before and after lipid infusion paralleled triglyceride levels. This patient developed cardiovascular collapse because of intentional, oral overdose of bupropion and lamotrigine that was initially refractory to standard resuscitation measures. An infusion of lipid emulsion was followed rapidly by restoration of effective circulation. Toxicologic studies are consistent with the lipid sink theory of antidotal efficacy.

Followed by a letter to the editor:

Cave G, et al. Ann Emerg Med. 2008;51:449-50.

To the Editor:

We wish to congratulate Sirianni et al on their case publication “Use of Lipid Emulsion in the Resuscitation of a Patient With Prolonged Cardiovascular Collapse After Overdose of Bupropion and Lamotrigine.” This represents a major step in the evolution of lipid emulsion as antidotal therapy in lipid-soluble drug cardiotoxicity, and is the first to demonstrate effect in an enteric overdose of lipid soluble drug.

Application of lipid infusion in local anesthetic-induced cardiotoxicity follows pioneering work by Weinberg and others demonstrating efficacy in animal models, and subsequently successful case publications. Re-establishment of new plasma equibrilium favoring sequestration of lipophilic drugs into a newly created intravascular compartment is the currently proposed mechanism of action. We have additionally demonstrated efficacy for lipid infusion in animal models of clomipramine and verapamil toxicity, suggesting potential benefit in deliberate overdose from these lipid soluble agents.

Guidelines advocating lipid emulsion as therapy for local anesthetic cardiotoxocity have recently been published by The Association of Anaesthetists of Great Britain and Ireland.6 We would endeavor to contribute to the “bringing over” of lipid therapy for lipophilic drug toxidromes from the anesthetic domain to the general toxicologic domain wherein we believe the greatest benefit is likely to be manifest.

The use of lipid emulsion as antidote should, however, progress with some caution. Enthusiasm and imprudence are common bedfellows in the commendation and application of novel medical therapies. The special setting encountered by Sirianni et al, that of refractory arrest despite all conventional therapy, is one where use of lipid emulsion is rational. The only potential alteration to outcome is benefit. Indiscriminate application of this therapy at the expense of validated antidotal therapies is unwarranted at this point. We would echo the call of the anesthetic literature for the use of lipid emulsion in the setting of lipophilic drug cardiotoxicity where death is adjudged inevitable despite all available alternative therapies.

Finally, as the nature and presentation of life-threatening lipophilic drug intoxication renders systemic human study impractical, animal modelling and case publication are likely to represent the avenues by which lipid therapy may advance. It is therefore the responsibility of individual clinicians to disseminate their experience with lipid therapy, both successes and otherwise. Moreover we would implore editors to publish such case reports both positive and negative. In time a major new therapy may be available to severely intoxicated patients.

20. Screening Laboratory and Radiology Panels for Trauma Patients Have Low Utility and Are Not Cost Effective

Tasse JL, et al. J Trauma 2008;65:1114-1116.

Background: Routine laboratory and radiology panels as part of the initial evaluation of the trauma patient are prevalent practices. This is a study of utility and cost effectiveness of this practice.

Methods: During a 3-month period, trauma panels were analyzed for cost and impact on patient care in our institution.

Results: Four hundred ten consecutive patients had 3,982 studies (cost $417,839) performed of which 1,292 (cost $114,753) were abnormal and only 253 (cost $36,703) were clinically contributory.

Conclusions: Routine panels are not useful or cost effective. Negative results contribute little to management. Selective and targeted studies should be indicated by the secondary survey, and may result in substantial cost savings ($1,500,000 per year at our institution).

21. Inability to get up after falling, subsequent time on floor, and summoning help: prospective cohort study in people over 90

Fleming J, et al. BMJ 2008;337:a2227

Objectives: To describe the incidence and extent of lying on the floor for a long time after being unable to get up from a fall among people aged over 90; to explore their use of call alarm systems in these circumstances.

Design: 1 year follow-up of participants in a prospective cohort study of ageing, using fall calendars, phone calls, and visits.

Setting: Participants’ usual place of residence (own homes or care homes), mostly in Cambridge.

Participants: 90 women and 20 men aged over 90 (n=110), surviving participants of the Cambridge City over-75s Cohort, a population based sample.

Main outcome measures: Inability to get up without help, lying on floor for a long time after falling, associated factors; availability and use of call alarm systems; participants’ views on using call alarms to summon help if needed after falling.

Results: In one year’s intensive follow-up, 54% (144/265) of fall reports described the participant as being found on the floor and 82% (217/265) of falls occurred when the person was alone. Of the 60% who fell, 80% (53/66) were unable to get up after at least one fall and 30% (20/66) had lain on the floor for an hour or more. Difficulty in getting up was consistently associated with age, reported mobility, and severe cognitive impairment. Cognition was the only characteristic that predicted lying on the floor for a long time. Lying on the floor for a long time was strongly associated with serious injuries, admission to hospital, and subsequent moves into long term care. Call alarms were widely available but were not used in most cases of falls that led to lying on the floor for a long time. Comments from older people and carers showed the complexity of issues around the use of call alarms, including perceptions of irrelevance, concerns about independence, and practical difficulties.

Conclusions: Lying on the floor for a long time after falling is more common among the "oldest old" than previously thought and is associated with serious consequences. Factors indicating higher risk and comments from participants suggest practical implications. People need training in strategies to get up from the floor. Work is needed on access and activation issues for design of call alarms and information for their effective use. Care providers need better understanding of the perceptions of older people to provide acceptable support services.

Lit Bits: November 28, 2008

From the recent medical literature...

1. Specialists Identify Clinical Features to Avoid TIA Misdiagnosis

Allison Gandey. November 21, 2008 — Neurologists are proposing 3 clinical features to help clinicians diagnose difficult-to-assess transient ischemic attacks (TIAs). In a study to be published in the December print issue of Cerebrovascular Diseases and published in the November 4 Online First issue, researchers report that only 40% of cases in the emergency department are true TIAs.

"There are not a lot of objective findings on which to base a diagnosis and this can be exceedingly challenging. Neurologists should be involved in the diagnosis," lead author Shyam Prabhakaran, MD, MS, from Rush University Medical Center in Chicago, Illinois, told Medscape Neurology & Neurosurgery.

To help bridge this gap, Dr. Prabhakaran's team developed a list of bedside clinical features designed to help clinicians in training, nonneurologists, and less experienced neurologists more accurately distinguish TIAs from nonischemic causes.

They identified 3 clinical characteristics:

Gradual symptom onset.
History of unexplained transient neurologic attacks.
Presence of nonspecific symptoms.

"Speed of onset, we found, was the strongest indicator of a TIA," Dr. Prabhakaran added in a news release. "I typically ask my patients if their symptoms came on like lightning — within seconds," he said. "With other neurological problems that can mimic a TIA — migraines or seizures — for example, symptoms take more than a minute to manifest."

The research team examined the records of 100 emergency department patients diagnosed with TIA and admitted for further evaluation.

After inpatient evaluation and review, final diagnoses were made by 2 neurologists. Of the 100 patients, 40 were confirmed to have TIA and 60 nonischemic transient neurologic attacks.

Table. Independent Predictors of Nonischemic Transient Neurologic Attacks
Characteristic Odds Ratio P Value
Gradual symptom onset 6.7 .002
History of unexplained attacks 10.6 .031
Presence of nonspecific symptoms 4.2 .008

"These data imply that without expert neurologic evaluation, a significant overestimation of the true prevalence and incidence of TIA is likely," the researchers write.

They also point to several limitations to their work, including the fact that it is a hospital-based study and is not generalizable to outpatient referral or a community setting. Also, because no gold standard exists to improve diagnostic accuracy for TIA, the final diagnosis can be questioned.

Still, investigators report that their 3 clinical features correctly classified 79% of study participants. These data may be useful in the education of clinicians and may help better triage patients in the emergency department, they note.

"It's important not to miss a diagnosis of TIA as these can be harbingers of stroke and patients need to be treated," Dr. Prabhakaran added. "But at the same time, we don't want to overdiagnose TIAs either. Overdiagnosis subjects patients to the risks of unnecessary and potentially dangerous medications and tests and leaves their actual condition untreated or inadequately managed."

The researchers have disclosed no relevant financial relationships.

Cerebrovasc Dis 2008;26:630-635.

2. In-Patient Hallway Boarding Lowers Mortality in Emergency Department Patients

Vicki Gerson. From American College of Emergency Physicians (ACEP) 2008 Scientific Assembly

October 30, 2008 (Chicago, Illinois) — Patients in the emergency department who are admitted to the hospital and wait for an available bed in an in-patient hallway instead of being "boarded" in the emergency department have no medical complications.

The number one challenge in hospital emergency departments is overcrowding. "There is a 26% increase in demand for emergency room care, while throughout the country, 425 emergency departments have closed," coauthor Adam Singer, MD, professor and vice chair for research at Stony Brook University Medical Center, Stony Brook, New York, told Medscape Emergency Medicine.

Dr. Singer and colleagues noted the consequences of overcrowding in emergency departments can result in treatment delays, increased medical errors, increased mortality, and patient and staff dissatisfaction. The study, which was conducted from January 2004 to January 2008, described the medical center's experience with transferring patients to in-patient hallways.

A physician identified admitted patients boarded in the emergency department who were appropriate for in-patient hallway boarding. Patients who need suctioning and those who require high flow oxygen or intensive care unit admissions were not admitted to in-patient hallways. Each hallway patient received a call bell and a privacy screen.

During the 4-year period, 278,975 people visited the emergency department, of which 57,487 were admitted, and 1798 patients died. "Of all admissions, 2036 went to hallways, 51,336 went to a standard bed (type of admit was unknown for 4115). Patients admitted to standard and hallway beds were similar in age (IQR [interquartile range], 55 [37 – 72 years]) and sex (48% female). The median (IQR) times from ED [emergency department] triage to actual admission in patients admitted to standard and hallway beds were 426 (306 - 600) and 624 (439 - 893), respectively."

Dr. Singer also told Medscape Emergency Medicine that 4% of the patients that were placed in hallways were similar in age and sex. The mortality rate was 2.6% for patients who went to a standard bed and 1.1% for patients who were first placed in the hallway. "There are no reported deaths to date while a patient was placed in the hallway while waiting for a room, as well as no safety concerns,” he said.

The researchers concluded emergency patients who were admitted to the hospital and held in an in-patient hallway to wait for a bed, instead of being "boarded" in the emergency department to wait, had mortality rates and intensive care unit admission rates of less than half that of patients in standard rooms. Boarding patients in the emergency department is harmful and harmful to the patients coming to the emergency department who experience delays in being seen by a physician who is attending to emergency department boarders.

Dr. Singer emphasized that overcrowding in the emergency department is not just an emergency department problem. "It is a hospital problem." He believes that by distributing in-patient hallway patients in the units does not affect patient care.

"I think this study is important in several ways," session moderator Jesse Pines, MD, assistant professor of emergency medicine and epidemiology at the University of Pennsylvania told Medscape Emergency Medicine. "It points out to hospital administrators the safety of a practice thought to be potentially unsafe is not and shows the ability of implementing a crowding solution. Other hospitals should consider trying it."

This study was funded by an EMF Grant given to the institution to assess overcrowding.

3. Controversy Swirls Around Early Goal-Directed Therapy in Sepsis: Pioneer Defends Ground-Breaking Approach to Deadly Disease

McKenna M. Ann Emerg Med. 2008;52:651-654 .

Plans to re-examine a research finding via a much larger set of clinical trials, a common event in medical research, have provoked an uncommon result: an unusually public airing in the mainstream media of allegations, financial questions and wounded professional pride.

The research finding at the center of the dispute is early goal-directed therapy for sepsis, formulated 7 years ago by Emanuel P. Rivers, MD, MPH, vice chairman and director of research in emergency medicine at Henry Ford Hospital in Detroit, MI. Dr. Rivers, who trained in critical care, emergency and internal medicine, proposed applying the “golden hour” to severe sepsis and septic shock.

His protocol identified patients and began treating them in the emergency department (ED), before they were admitted to intensive care. It deployed a bundle of conventional measures—early recognition of patients with a high risk of death using blood lactate levels or hypotension and giving antibiotics, fluid therapy titrated to central venous pressure, vasopressors if required to maintain blood pressure, hemoglobin concentration above 10 mg/dl using transfusions if required, and maintaining central venous blood oxygen saturation above 70% using medication (Inotropes) to improve perfusion.

And it had dramatic results. Dr. Rivers' protocol cut the mortality rate in the 130 patients who received it to 30.5%, compared to 46.5% among the 133 patients treated with the hospital's standard care—a drop in deaths so striking that the study's data safety monitoring board decided to end it early. That seemed a significant advance for a disease that affects 750,000 Americans each year and costs from $16.7 2 to $24 billion and that had had an intractable mortality rate for 3 decades. Rivers' protocol was adopted by the Surviving Sepsis Campaign, which is endorsed by the American College of Emergency Physicians and the Society of Critical Care Medicine, and is recommended by the Institute for Healthcare Improvement.

Early goal-directed therapy drew some criticism from the start,6 and EDs were slow to adopt it: 3 years after it was published, a survey of 30 academic medical center EDs, found only 2 using the protocol. (There is no registry of EDs that use early goal-directed therapy, but it has been adopted by several large health systems, and a July 2008 paper8 surveyed 40 hospitals now using it.)

Departments that have adopted it are enthusiastic. In a 2006 article in Chest, describing a yearlong trial at Cooper University Hospital in Camden, NJ, Stephen Trzeciak, MD, MPH, declared that early goal-directed therapy “could reliably be achieved in real-world clinical practice.” And later that year, authors from 9 institutions, including Trzeciak and Rivers, reported the outcomes of implementing early goal-directed therapy in 12 institutions other than Henry Ford; all 12 had comparable declines in sepsis mortality rates.

“Unnamed Sources”
Overall, at least 25 papers supporting the Rivers protocol have been published since 2001, according to the PubMed database. A recent meta-analysis of 9 studies covering 1,001 patients confirmed that the protocol reduces sepsis deaths.

But early goal-directed therapy has still faced questions. They range from the relatively small size of Rivers' original study, the fact that it was conducted at a single institution, and the reality that it remains the only randomized clinical trial of early goal-directed therapy; to the necessity of the specific monitoring catheter; to whether the protocol is reproducible in thinly staffed community hospitals and very crowded urban EDs.

In response, the National Institutes of General Medical Sciences, part of the National Institutes of Health, announced in late 200613 that it would grant $8.4 million over 5 years to test the Rivers protocol in a much larger randomized trial. The study, called ProCESS (Protocolized Care for Early Septic Shock), plans to enroll 1,935 patients at 24 institutions and will be directed by investigators at University of Pittsburgh Medical Center.

So far, so normal: a creative researcher produces a path-breaking finding, and after a period of exploration and debate, the finding is re-examined for reproducibility. “It is a basic tenet of scientific investigation that you should be able to replicate a work in a different and bigger setting to make sure it is truly helpful,” said Donald Yealy, MD, of the University of Pittsburgh, one of the ProCESS trial's principal investigators. (Yealy is a deputy editor of Annals but was not involved in the preparation of this story.)

Dr. Rivers Responds
But the next step in the saga of early goal-directed therapy has been somewhat outside the norm. On August 14, the Wall Street Journal ran a front-page article that questioned both Rivers' analysis and his ethics.

Full-text: http://www.annemergmed.com/article/S0196-0644(08)01897-0/fulltext

4. Benefits of Prehospital Notification for Stroke Patients

Prehospital ED notification decreased door-to-CT time by 23% and doubled use of thrombolytic therapy.

Early identification and management of acute stroke are critical for improving outcomes. To examine the effects of advance notification of the arrival of stroke patients, researchers retrospectively analyzed data for 118 patients with acute stroke who were transported by emergency medical services directly from the scene to a single tertiary care emergency department within 6 hours of symptom onset during a 16-month period.

EMS staff provided advance notification to ED staff for 44 patients. No significant differences in age, sex, stroke history, or median National Institutes of Health Stroke Scale scores were noted between patients for whom prehospital notification was and was not given. Prehospital notification was associated with significantly shorter door-to-computed tomography (CT) time than no prehospital notification (median time, 40 vs. 47 minutes). In multivariable linear regression modeling, prehospital notification reduced door-to-CT time by 23%. Nine patients for whom prehospital notification was given and none for whom notification was not given had prolonged door-to-CT times (2–5 hours). All patients were evaluated by a vascular neurologist. Overall, 29% of patients received thrombolytic therapy (intravenous tissue plasminogen activator [TPA] in 20; IV TPA followed by intra-arterial thrombolysis in 12; and intra-arterial thrombolysis alone in 2). Patients who arrived at the ED after prehospital notification were twice as likely as those who arrived without advance notice to receive thrombolytic therapy (42% vs. 21%).

Comment: As expected, analogous to prehospital activation of the cath lab for patients with ST-segment-elevation myocardial infarction, prehospital notification of the ED allows mobilization of hospital resources for incoming stroke patients. Prehospital notification for stroke already is a class I recommendation of the American Heart Association. Why advance notification was not given for 63% of patients in this study is not known. Most disturbing is that even when advance notification was provided, patients did not get CT scans within the recommended 30 minutes. Although the window of time for stroke treatment is widening to 4.5 hours (JW Emerg Med Sep 15 2008 and Sep 24 2008), that is not a license for delay. Time to CT is a key driver of rapid thrombolytic therapy and requires close attention.

— Kristi L. Koenig, MD, FACEP. Published in Journal Watch Emergency Medicine November 7, 2008. Citation: Abdullah AR et al. Prehosp Emerg Care 2008; 12:426.

5. CT Important in Emergency Diagnosis of Appendicitis

NEW YORK (Reuters Health) Oct 30 - CT of the appendix has a significant impact on the management of emergency department patients who are suspected of having appendicitis, researchers report in the October issue of the American Journal of Roentgenology.

Dr. Robert O. Nathan of the University of Washington, Seattle, and colleagues note that despite the apparent value of CT under these circumstances, it has not been determined whether the approach should be used in all such patients.

To investigate further, the researchers studied data on 100 consecutive patients who attended a community hospital emergency department and underwent appendix CT.

In 3 of the 5 patients in whom appendicitis was considered very likely, CT determined that this was not the case. This was also true of 9 of 18 in whom appendicitis was considered to be likely.

However, in all 20 patients who considered to be unlikely to have appendicitis, CT results were in accordance.

Overall, CT scans led to a change in the treatment plans of 29% of the patients. The approach had a sensitivity of 94%, a specificity and positive predictive value of 100%, and a negative predictive value and accuracy of 99%.

"The data suggest that CT can be withheld in patients in whom emergency clinicians rate the likelihood of appendicitis as unlikely but that CT findings are often of benefit even when appendicitis is judged to be very likely," the researchers conclude.

Am J Roentgenol 2008;191:1102-1106.

6. Clinical Markers May Help Detect Abusive Head Trauma in Young Children

Clinical Context
Inflicted head injury is the leading cause of death in children who are abused. Characteristics of the child at risk for abusive injury include age younger than 1 year, prematurity at birth, and multiple birth, whereas family characteristics include younger mother, single mother, low socioeconomic status, and late or no prenatal care.

This is a retrospective chart review of children who underwent computed tomography scans, conducted at the National Center for Child Health and Development in Japan, to examine factors associated with AHT and factors that distinguish AHT from non-AHT.

Laurie Barclay, MD. October 30, 2008 — Several clinical markers evaluated at a medical visit may help detect abusive head trauma (AHT) of young children, according to findings of a comparative case series study reported in the October issue of Pediatrics.

"Distinguishing abusive head trauma in young children from other diseases by symptoms is difficult in practice," write Takeo Fujiwara, MD, PhD, MPH, from the National Institute of Public Health in Saitama, Japan, and colleagues. "Comparisons between abusive and nonabusive head trauma in young children in Japan, where computed tomography is widely and easily available, might contribute to identifying markers of abusive head trauma that differ from that in Western countries. The objective of this study was to compare the characteristics of abusive and nonabusive head trauma in young children in Japan."

A retrospective medical chart and social work record review identified 260 children who were aged 0 to 2 years, visited the National Center for Child Health and Development (Tokyo, Japan) from March 1, 2002, to December 31, 2005, and underwent computed tomography scanning because of suspected intracranial injury. Demographic and perinatal characteristics, injury history, clinical presentation, and outcomes were compared in patients with abusive or non-AHT, based on the published definition, using chi-square and Fisher's exact tests.

Compared with patients with non-AHT, those with AHT were significantly younger, with peak incidence at ages 2 to 4 months and ages 7 to 9 months. Other clinical markers associated with AHT were no injury history given by the caregiver (60.7%); neurologic symptoms such as unconsciousness, seizure (32%), or paralysis; subdural hemorrhage; and retinal hemorrhages.

Despite the severity of clinical outcomes in patients with AHT, social welfare services separated only 32% of these patients from the caregiver.

"This study highlights the several clinical markers to detect abusive head trauma at a medical visit, including an absence of injury history, neurologic symptoms, subdural hemorrhage, and retinal hemorrhage," the study authors write. "These markers can be used to detect abusive head trauma cases by physicians and social welfare workers to protect children from additional abuse."

Limitations of the study include retrospective design, which may lead to misclassification; funduscopy and skeletal surveys not completed in some cases; criteria used might inflate the number of AHT cases; small sample size; and study performed only in 1 hospital, limiting generalizability.

"Similar clinical presentations of AHT with previous studies in Western culture (ie, the absence of an injury history, seizures, SDHs [subdural hemorrhages], and retinal hemorrhages) were also found in Japan," the study authors conclude. "The 2 peaks of age, at 2 to 4 months and 7 to 9 months, might be a characteristic unique to Japan....The CGC [Child Guidance Center] should be encouraged to consider these findings for making better informed decisions regarding children who are referred to CGC."

Pediatrics. 2008;122:e841-e847.

7. Being Difficult: For Some Patients, It's a Coping Mechanism

By Sandra G. Boodman. Special to The Washington Post. Tuesday, October 21, 2008; Page HE01

It's fashionable in health care to talk about the importance of being a knowledgeable, assertive patient and of forging a working partnership with a doctor, a relationship that will speed healing or improve the process of living with a chronic, even life-threatening, illness.

But as Michelle Mayer, a nurse with a doctorate in public health, discovered, the path to achieving such an alliance often is not an easy one.

Married to a Duke University physician, Mayer said she never set out to become difficult, the sort of patient who is the bane of many doctors. But as she wrote in the current issue of the journal Health Affairs and documented on her blog, http://diaryofadyingmom.blogspot.com, being com-pliant was bad for her health.

Challenging her doctors' advice and making decisions that at times diverged from their recommendations, she wrote, helped her wage a 12-year battle with scleroderma, an incurable and sometimes fatal autoimmune disorder that causes hardening of the skin. Mayer's illness was diagnosed when she was 27; her initial symptoms included extreme fatigue and uncontrollable itching.

"I tried being the 'good patient,' " said Mayer, who until illness forced her to retire was an assistant research professor in the school of public health at the University of North Carolina at Chapel Hill. Becoming difficult -- some, she said, might call it "empowered" -- was her "natural reaction" to doctors who were "incompetent, rude or domineering."

Full-text: http://www.washingtonpost.com/wp-dyn/content/article/2008/10/17/AR2008101702677.html

8. Images in EM

a. Adolescent With Rash and Cough

Heilbrunn BR, et al. Ann Emerg Med. 2008;52:606.

A 12-year-old girl from rural Indiana presented to the emergency department for temperature of 40°C (104°F), cough, and a painful rash on her legs. Her symptoms began 1 month previously with cough and fever, with subsequent development of rash.

Evaluation revealed a nontoxic, well-developed 12-year-old. She had a pulse of 142 beats/min, respiratory rate of 18 breaths/min, blood pressure of 110/67 mm Hg, and room air oxygen saturation of 99%. Her physical examination result was notable for anterior cervical adenopathy and tender erythematous nodular lesions on her lower extremities (Figure 1). Chest radiograph and chest computed tomographic scan are also included (Figure 2, Figure 3).

http://www.annemergmed.com/article/S0196-0644(08)01462-5/fulltext

b. Adult Female With Pink Nodules on Skin

Saleh M, et al. Ann Emerg Med. 2008;52:616

53-year-old healthy woman presented with a complaint of a painless pink nodule resembling an insect bite that started on her hand and progressed to the rest of her upper extremity (Figure 1, Figure 2). The symptoms started 3 weeks after gardening in her yard. She was treated with a 10-day course of antibiotics by her physician, without improvement. The patient began receiving antifungals, and a culture subsequently confirmed the diagnosis.

http://www.annemergmed.com/article/S0196-0644(08)01565-5/fulltext

9. Resistance to Fluoroquinolones Increasing in Outpatient Urinary E. Coli Isolates

By Will Boggs, MD. NEW YORK (Reuters Health) Nov 13 - Fluoroquinolone resistance in outpatient urinary Escherichia coli isolates has increased after recommendations for their use for empiric treatment of urinary tract infections, according to a report in the October issue of The American Journal of Medicine.

"Management of urinary tract infections, a common reason for antibiotic use in adults, is complicated by rising resistance of Escherichia coli to oral antibiotics," Dr. Connie Savor Price told Reuters Health. "Rapid emergence of fluoroquinolone resistance in E. coli following increased prescribing suggests further use would make fluoroquinolones unreliable for treatment within a short time."

Dr. Price, from Denver Health and Hospital Authority, Colorado, and colleagues examined the relationship between levofloxacin use and the emergence of fluoroquinolone-resistant E. coli in an adult outpatient population.

During a period when outpatient fluoroquinolone prescriptions increased from 3.8 prescriptions per 1000 outpatient visits (1998) to 12.8 prescriptions per 1000 outpatient visits (2005), levofloxacin resistance increased from 1% of all E. coli isolated in the outpatient setting to 9.4%, the authors report.

Virtually all levofloxacin-resistant E. coli were fully resistant, and 78% of isolates were resistant to two or more additional antimicrobial classes. Only a minority of isolates remained sensitive to trimethoprim-sulfamethoxazole (34.1%) or ampicillin (22.0%).

"Although antibiotic use predictably leads to resistance, we did not anticipate the pace of the emergence of resistance," the investigators say. "In just 6 years, levofloxacin resistance increased more than 5-fold."

"When possible," Dr. Price said, "as in most cases of simple cystitis, fluoroquinolone-sparing regimens should be utilized to preserve this important class of antibiotic. For simple cystitis, we are advocating nitrofurantoin for patients without contraindications."

Am J Med 2008;121:876-884

10. Procedural Sedation Is Safe for Children Younger Than 2 Years

About 6% of children who were sedated with combinations of ketamine, morphine, and midazolam experienced adverse events, all of which were minor, except for one case of respiratory failure.

Misra S, et al. Int J Emerg Med 2008;1:173–177.

Introduction
Providing relief from pain and anxiety associated with diagnostic and therapeutic procedures has become an ethical imperative in children as well as a measured quality indicator from the family’s perspective. This, along with a tremendous increase in the number of procedures performed on children outside the operating room, has led to non-anesthesiologists, particularly emergency physicians, taking a key role in the administration of procedural sedation and analgesia (PSA) to children. It has been estimated that roughly a quarter million children will receive PSA in the emergency departments (EDs) annually and that children under 2 years of age constitute roughly 20–30% of those. It has been shown that pain in infants and toddlers is poorly recognized and documented, predisposing them to receive less analgesia when compared with older children.

Commonly used medications for PSA such as ketamine are relatively contraindicated in very young children (less than 6 months of age) because of an association with increased risk of airway complications. Inadequate sedation and analgesia predisposes to procedural failure, parental anxiety and dissatisfaction, and poor quality of care. The anatomic differences in the airway like smaller airway diameter, longer and floppy epiglottis, and the physiologic differences in drug metabolism between younger and older children could predispose younger children to a higher risk for adverse events related to sedation. Studies have shown contrasting results regarding association of age and adverse events related to PSA. While some studies have found children less than 2 years of age to be at an increased risk for adverse events related to PSA, other studies have found no association between age and adverse events related to PSA. To our knowledge, there have been no studies that have focused exclusively on PSA in children less than 2 years of age. The main objective of our study is to describe PSA in children less than 2 years of age in the ED of a tertiary care children’s hospital. Additionally, we will describe the indications for PSA, medications used, efficacy of sedation, and adverse events related to sedation in this group of children.

Full-text (pdf): http://www.springerlink.com/content/2v2q153557p1m741/fulltext.pdf

11. How Common Is Aspirin Resistance?

True resistance occurred in only 5% of patients; other "resistance" was attributed to dosing nonadherence.

Aspirin acetylates the cyclooxygenase (COX)-1 enzyme, thereby preventing the conversion of arachidonate to thromboxane A2 (TxA2), a powerful platelet-aggregating agent. Based on this and other antithrombotic properties of aspirin (attenuation of fibrin cross-linking and augmentation of clot permeability and lysis), this agent has become a mainstay in the management of patients with atherothrombotic disorders. However, disturbing reports of aspirin resistance have weakened confidence in the effectiveness of this inexpensive and readily accessible drug. Patients are considered resistant to aspirin if ex vivo tests of platelet function show lack of inhibition, if production of TxA2 continues during aspirin therapy, or if thrombosis recurs. Yet another — largely unexplored — reason for aspirin resistance might be lack of adherence in taking the drug.

To evaluate the relation between aspirin resistance and adherence, Italian investigators performed a prospective study of 100 consecutive patients who had been undergoing continuous aspirin therapy for 6 months. In 69 participants, platelet aggregation and thromboxane metabolite concentration measures were consistent with the expected effects of aspirin. The remaining 31 "aspirin-resistant" patients were entered into a controlled program in which they were given 100 mg of aspirin daily for 7 days and carefully monitored for adherence.

Repeat laboratory testing after 7 days showed full aspirin effect in 26 of these patients, which suggested that they were not resistant but rather were nonadherent with their previous aspirin therapy. The five remaining patients also demonstrated resistance after receiving a second 7-day course of aspirin at a higher dose (325 mg daily), thus verifying that they were truly aspirin-resistant. The three groups (aspirin-sensitive, aspirin-nonadherent, and aspirin-resistant patients) had similar histories of cardiovascular disease and risk factors. Further analyses revealed that patients who were taking more than six tablets of prescribed medications daily were significantly more likely to be nonadherent than were those taking fewer medications (P less than 0.001). The number of prescribed medications predicted poor adherence independent of patient age; gender; or history of previous stroke, myocardial infarction, hypertension, diabetes, or dyslipidemia.

Comment: The authors found that true aspirin resistance occurred in only 5% of patients. Poor adherence with dosing — which was more likely among patients taking more than six tablets of various medications daily — accounted for 84% of presumed drug resistance. The message of this study might be applicable to many other situations in which patients are instructed to take several drugs concomitantly: Failure to observe a positive response might be due to poor adherence rather than to drug resistance. Explaining why a drug is being given, stressing the importance of adhering to instructions, and monitoring patients carefully for dosing adherence are necessary to ensure optimal outcomes.

— David Green, MD, PhD. Published in Journal Watch Oncology and Hematology November 18, 2008. Citation: Pignatelli P et al. J Thromb Haemost 2008;6:1832.

12. CT Perfusion Scan Spots Acute Stroke in the Emergency Setting

By Megan Rauscher. NEW YORK (Reuters Health) Nov 11 - Computed tomography (CT) perfusion imaging can be used to diagnose acute ischemic stroke in the emergency department more rapidly than magnetic resonance imaging (MRI), the standard for stroke diagnosis, according to results of a large single-center study.

"We looked at over 400 patients and found CT perfusion scans to be very accurate and rapid -- within 5 minutes of the patient getting on the CT scanner table you can have an answer, as opposed to MRI, which takes half an hour," Dr. Ansaar T. Rai noted in a telephone interview with Reuters Health.

"Our study reveals that the widespread use of CT perfusion is a practical way to help busy emergency departments save precious time in stroke diagnosis, target treatment and reduce the risks of inappropriate thrombolytic use," Dr. Rai added in a university statement.

Dr. Rai, from the department of radiology, West Virginia University Health Sciences Center in Morgantown, and colleagues retrospectively reviewed 422 patients who underwent CT perfusion for suspected stroke. CT perfusion abnormalities were correlated with subsequent diffusion weighted image (DWI) abnormalities seen on MRI performed within 1 week of CT.

Of 157 acute ischemic strokes confirmed by MRI, 78 showed CT perfusion abnormalities (sensitivity 49.7%).

However, after excluding small non-vascular territory strokes, there were 77 acute ischemic strokes with total volume of infarcted tissue of more than 5 cc by DWI. Of these, 71 showed CT perfusion abnormalities, yielding a sensitivity of 92.2%, the investigators report in the October issue of the Journal of Emergency Medicine.

Of the 265 patients without acute ischemic stroke, none showed CT perfusion abnormalities, yielding a specificity for detecting ischemic stroke of 100%.

It's worth noting, the researchers say, that the average time between emergency room neurological exam and CT scan was only 35 minutes.

They conclude that CT perfusion imaging is effective for diagnosing major strokes "that result in more devastating outcome."

"Every hospital has a CT scanner -- that's why we chose this modality," Dr. Rai commented, "and by doing this test, we can tell with a very fair degree of certainty whether a person is having a major ischemic stroke -- the kind that if treated quickly can really help the patient avoid major disability."

J Emerg Med 2008;35:287-292.

13. The Management of STEMI Patients

a. The Accuracy of an Out-of-Hospital 12-Lead ECG for the Detection of ST-Elevation Myocardial Infarction Immediately After Resuscitation

Müller D, et al. Ann Emerg Med. 2008;52:658-664.

Study objective
Severe myocardial ischemia is the leading cause of arrhythmic sudden cardiac death. It is unclear, however, in which percentage of patients sudden cardiac death is triggered by ST-elevation myocardial infarction (STEMI) and whether the diagnosis of STEMI can be reliably established immediately after resuscitation from out-of-hospital sudden cardiac death.

Methods
A 12-lead ECG was registered after return of spontaneous circulation after cardiac arrest. After hospital admission, further ECG, creatine kinase MB, and troponin measures; results of coronary angiograms; and autopsies were evaluated to confirm the definitive diagnosis of STEMI.

Results
Seventy-seven patients were included in our study (67% men, age 64 [14 to 93] years). STEMI was diagnosed in 44 patients. The diagnosis of myocardial infarction was confirmed in 84% of the 77 patients who survived to hospital admission. The sensitivity of the out-of-hospital ECG was 88% (95% confidence interval [CI] 74% to 96%), the specificity 69% (95% CI 51% to 83%), the positive predictive value 77% (95% CI 62% to 87%), and the negative predictive value 83% (95% CI 64% to 87%). The accuracy of the out-of-hospital ECG and that registered on admission was the same.

Conclusion
The diagnosis of STEMI can be established in the field immediately after return of spontaneous circulation in most patients. This may enable an early decision about reperfusion therapy, ie, immediate out-of-hospital thrombolysis or targeted transfer for percutaneous coronary intervention.

b. Transferring Patients With ST-Segment Elevation Myocardial Infarction for Mechanical Reperfusion: A Meta-Regression Analysis of Randomized Trials

De Luca G, et al. Ann Emerg Med. 2008;52:665-676.

Study objective
Primary angioplasty is associated with benefits in survival as compared with thrombolysis among patients with ST-segment elevation myocardial infarction (STEMI). However, in daily practice only a minority of STEMI patients are admitted to 24-hour primary percutaneous coronary intervention hospitals. A previous meta-analysis failed to show significant benefits in terms of survival, potentially because of a limited statistical power. Thus, the aim of the current study is to perform an updated meta-analysis of randomized trials to evaluate whether transfer for primary angioplasty provides significant benefits in terms of survival compared with on-site thrombolysis among STEMI patients.

Methods
The literature was scanned by formal searches of electronic databases (MEDLINE, CENTRAL, EMBASE) and the Cochrane Central Register of Controlled trials (http://www.mrw.interscience.wiley.com/cochrane/Cochrane_clcentral_articles_%20fs.html) from January 1990 to April 2008. The following key words were used: “randomized trial;” “myocardial infarction;” “reperfusion;” “thrombolysis;” “primary angioplasty;” “angioplasty;” “mechanical reperfusion;” “facilitation;” “transfer;” “transportation;” “mortality;” and “survival.” Inclusion criteria were (1) randomized comparison between on-site thrombolysis and transferring for primary angioplasty; and (2) complete data on mortality. We did not exclude trials or trial arms that specifically addressed transfer for percutaneous coronary intervention after thrombolysis. Crude data were extracted by 2 investigators. No language restrictions were enforced. The relationship between benefits in mortality and reinfarction, baseline mortality of the thrombolytic group in each study (study level variable), and percutaneous coronary intervention-related time delay was evaluated by using a weighted least-square regression.

Results
A total of 11 randomized trials were identified, including 5,741 patients (51.8% transferred for primary angioplasty and 48.2% treated with thrombolysis). Transfer for primary angioplasty was associated with a significant reduction in mortality (5.6% versus 6.8%; P=.02), reinfarction (2.1% versus 4.7%; P less than .0001 and stroke (0.7% versus 1.7%, P=.0005) at 30-day follow-up. The benefits in mortality and reinfarction of transfer for primary percutaneous coronary intervention over thrombolysis were not significantly related to baseline mortality of the lytic group or to percutaneous coronary intervention-related time delay.

Conclusion
This meta-analysis demonstrates that, among STEMI patients, transfer for mechanical reperfusion is associated, in addition to benefits in reinfarction and stroke, with a significant reduction in mortality at 30-day follow-up.

14. Does this work for you?

Christakis NA. BMJ 2008;337:a2281

To say a drug "works" is only half the story

Doctors say that a drug "works" if, in comparison with the control arm of a clinical trial, significantly more people in the treatment arm respond. Unfortunately, this is a naive oversimplification, and it breeds complacency among patients and physicians alike.

Criticisms of this perspective have been lodged before. One is that researchers often pick outcomes that are not patient centred—patients do not care if a tumour shows "shrinkage upon radiological visualisation" but rather whether they are in less pain. Another criticism is that when side effects of drugs are factored in, many patients do not think that a drug works very well at all, even as the doctor or drug company extols its virtues; drop-out rates in the active agent arm of trials often exceed those of the placebo arm, providing evidence of patients’ distaste for the overall effects of a drug.

But one problem that has received far less attention is that when patients say a drug "works" they typically mean something quite different from what doctors mean. Patients mean that most patients respond to the drug. This, however, is rarely the case. In fact, some of the most prescribed drugs today have no effect in most patients who take them.

For example, sildenafil (Viagra) works less than half the time: even when used in a dose optimised fashion (where the dose is titrated from 25 mg to 200 mg), and when effectiveness is gauged by the number of men who report that at least 60% of attempts at sexual intercourse are successful, only 48% of men are found to respond to the drug (compared with 11% who respond to a placebo) (BMC Urology 2002;2:6, doi:10.1186/1471-2490-2-6). When the 25 mg dose of the drug is used, 28% of the men report success (compared with 10% in the placebo arm). Most patients taking sildenafil should thus not expect it to "work." In fact, we could quite honestly tell patients that the 25 mg dose does not work 72% of the time.

The use of pregabalin to treat post-herpetic neuralgia provides a similar example. Roughly 50% of patients report that their pain scores drop by half or more, compared with 20% of patients who received a placebo (Neurology 2003;60:1274-83). At least half of patients, in other words, would not think that this drug has worked by this measure of success.

An alternative way of seeing the same phenomenon is to ask how often placebo "works." Consider the use of atorvastatin to prevent cardiovascular disease. The ASCOT trial, which followed more than 10 000 patients for an average of 3.3 years, found that 1.9% of people who were taking the drug had a heart attack, whereas among the patients taking a placebo the figure was 3% (Lancet 2003;361:1149-58, doi:10.1016/S0140-6736(03)12948-0). This is an impressive difference, yet many patients might not want to take the drug if they were told that a placebo worked at least 97% of the time.

Countless drugs that have been shown in randomised controlled trials to be effective work in only a minority of patients. Imagine that a drug worked 20% of the time in a trial, compared with 5-10% for a placebo. This is the case for drugs ranging from antihypertensives to minoxidil to cancer chemotherapy. Such a difference in a trial corresponds to an enormous effect size. However, most patients taking such drugs would not benefit—they would hardly think that the drugs "worked."

If you buy a toaster you expect it to be able to toast bread every time it is used. If it does not, you say it does not work and return or discard it. You do not take solace from the claim that, in fact, 30% of the time in the manufacturer’s laboratory the toaster did a better job in browning bread than sunshine alone.

My point is not that drugs evaluated in randomised controlled trials are not terrific. They are. And the scientific evidence for their efficacy is impressive. Rather, the problem is that patients and doctors lose sight of what trials actually show and either have false expectations of drugs’ effectiveness or are unaware that they should be vigilant about the possibility that the drug may have no effect whatsoever in any one person and hence fail to consider the need to switch or stop taking the drug.

Attention to variation in a patient’s response is thus essential for any drug that does not affect nearly 100% of patients. The variation in response involves two parts: that related to observable factors (such as age or clinical status) and unpredictable variation. Because the original clinical trials showing that drugs work are rarely powered to look at variation in observable factors, post-marketing observational studies are needed to determine which patients, on average, do or do not respond.

As for the unpredictable variation, one appropriate reaction is to have a protocol of administration that evaluates a patient’s response. Doctors sometimes already do this in a systematic way (such as when titrating the administration of highly active antiretroviral treatment). But this practice should be more widespread and more formal—and should especially be implemented in the case of drugs that have been shown to benefit only a minority of patients.

Just because drugs work in trials does not mean they will work in our patients. In fact, we can often expect that they will not work at all.

15. CPR by Paramedics for Cardiac Arrest: First Focus Is to Restore Pulse in the Field

from Heartwire — a professional news service of WebMD. November 4, 2008 (Chicago, IL) — Significantly more adult patients with cardiac arrest had their heartbeats restored by emergency-medical service (EMS) personnel in Los Angeles after adoption of cardiopulmonary-resuscitation (CPR) guidelines that emphasize treatment at the scene before any effort to transport to a hospital, investigators reported here last week at the American College of Emergency Physicians Scientific Assembly 2008 [1]. Their prospective study was limited to bystander-witnessed out-of-hospital cardiac arrest not associated with trauma.

The rate of return of spontaneous circulation (ROSC) was about 70% higher (p less than 0.0001) in 2007 compared with 2000 before adoption of the new protocol, which downplays restoration of ventilation in favor of uninterrupted chest compressions and advanced life-support efforts sustained for at least 20 minutes.

And thanks to a refined procedure for calling an end to resuscitation efforts in the field, there were significantly fewer "futile transports" in 2007, study presenter Dr Marc Eckstein (University of Southern California, Los Angeles), told heartwire.

If no pulse is restored after 20 minutes, the city's fire-department–based EMS personnel can remotely contact a physician for authorization to terminate the resuscitation effort, said Eckstein, who is medical director of the Los Angeles Fire Department and was previously a New York City paramedic.

For the most part, he said, "the only patients who will have a neurologically intact survival are going to be those who get a pulse back in the field." By definition, prepping the patient for transport interrupts chest compressions, which diminishes chances for survival. "If the patient is delivered [to the hospital] with CPR in progress, that patient probably isn't going to survive."

Revamped procedures in the protocol in 2007 compared with 2000 included two minutes of chest compressions as the first action taken, followed by a defibrillator shock, and then immediate resumption of compressions--without taking time for a pulse check, according to Eckstein. Less priority is given to intubation, and care is taken to avoid hyperventilation. "The point is to minimize interruptions in chest compressions, because that's a critical component for maintaining coronary perfusion pressure," he said.

"Obviously change is difficult in a very large system like ours, but the preliminary data are very encouraging."

Patients who regain a pulse undergo 12-lead electrocardiography, Eckstein said; those with likely infarction are transported to the closest "STEMI receiving center" for catheterization and possible intervention.

Futile transports were fewer due to the significant increases in cases in which resuscitation efforts were terminated in the field. The rate in 2000 was 9% of the 1700 patients with out-of-hospital cardiac arrest that were either witnessed or not witnessed, compared with 27% of the 1607 such patients in 2007 (p less than 0.0001).

With recent guidelines' emphasis on chest-compression-only CPR for the public, which do not recommend assisted breathing, "we hope we'll see a big increase in the rate of bystander CPR, because that's been a big impediment to improving the survival rate all these years," according to Eckstein.

He also said the next step in the research is to compare outcomes data from hospitals that received the patients who were successfully resuscitated, to determine whether the updated CPR protocol increased the percentage who were discharged neurologically intact.

Eckstein M. Impact of new CPR/advanced cardiac life support guidelines on outcome from out-of-hospital cardiac arrest. American College of Emergency Physicians Scientific Assembly 2008; October 28, 2008; Chicago, IL. Abstract 87.

16. Counseling May Reduce Clinician Burnout and Stress

Laurie Barclay, MD. November 18, 2008 — A short-term counseling intervention was effective in reducing burnout and stress in a cohort of Norwegian clinicians, according to the results of a study published online November 12 in the British Medical Journal.

"Research on the mental health of doctors has led to a call for preventive interventions to lower the risk of burnout and mental distress," write Karin E. Isaksson Rø, MDr, from the Research Institute, Modum Bad, in Vikersund, Norway, and colleagues. "Early intervention programmes could ensure that practising doctors in trouble get help in time, before their problems interfere with care of patients and give rise to medical errors, but such programmes have been poorly investigated."

At a Norwegian resource center, 227 physicians participated in a counseling intervention during 2003 to 2005 and completed a self-reported assessment at 1 year. The intervention consisted of individual counseling lasting 1 day or group-based counseling lasting 1 week, aimed at motivating reflection on and acknowledgement of the physicians' situation and personal needs. Primary endpoints were levels of burnout, measured with the Maslach burnout inventory, and predictors of reduced emotional exhaustion, based on linear regression.

Of 185 physicians (81%) who completed 1-year follow-up, 88 were men and 97 were women. On a scale of 1 to 5, the mean level of emotional exhaustion significantly decreased from 3.00 ± 0.94 to 2.53 ± 0.76 (t = 6.76; P less than .001), which was similar to the level found in a representative sample of 390 Norwegian physicians. In addition, participants had decreased their working hours by 1.6 ± 11.4 hours/week.

The proportion of physicians on full-time sick leave decreased from 35% (63 of 182 physicians) at baseline to 6% (10 of 182 physicians) at follow-up, and the proportion that had undergone psychotherapy increased from 20% (36 of 182 physicians) to 53% (97 of 182 physicians). After adjustment for sex, age, and personality dimensions, reduction in emotional exhaustion in the overall cohort was independently associated with reduced number of work hours per week (β = 0.17; P = .03). Among men, "satisfaction with the intervention" was an independent predictor of reduced emotional exhaustion (β = 0.25; P = .04).

"A short term counselling intervention could contribute to reduction in emotional exhaustion in doctors," the study authors write. "This was associated with reduced working hours for the whole cohort and, in men, was predicted by satisfaction with the intervention."

Study limitations include an inability to determine causality, lack of further analyses of subgroups possibly causing a false negative finding (type 2 error), regression analyses for each sex also subject to possible type 2 errors, and possible recall bias.

"Considering doctors' reluctance to seek help, despite high levels of distress, it is important to offer interventions that facilitate access and that can enhance motivation to reconsider personal and professional priorities when necessary," the study authors write. "The indications of factors possibly contributing to reduction in emotional exhaustion need to be further investigated with a more controlled design."

The Norwegian Women's Public Health Association and Modum Bad psychiatric hospital supported this study. Dr. Rø has been employed at the resource center, Villa Sana, and was reimbursed for a presentation of preliminary results at an internal meeting of the Norwegian Medical Association.

BMJ. Published online November 12, 2008.

17. The Relative Efficacy of Meperidine for the Treatment of Acute Migraine: A Meta-analysis of Randomized Controlled Trials

Friedman BW, et al. Ann Emerg Med. 2008;52:705-713.

Study objective
Despite guidelines recommending against opioids as first-line treatment for acute migraine, meperidine is the agent used most commonly in North American emergency departments. Clinical trials performed to date have been small and have not arrived at consistent conclusions about the efficacy of meperidine. We performed a systematic review and meta-analysis to determine the relative efficacy and adverse effect profile of opioids compared with nonopioid active comparators for the treatment of acute migraine.

Methods
We searched multiple sources (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and LILACS, emergency and headache medicine conference proceedings) for randomized controlled trials comparing parenteral opioid and nonopioid active comparators for the treatment of acute migraine headache. Our primary outcome was relief of headache. If this was unavailable, we accepted rescue medication use or we transformed visual analog scale change scores by using an established procedure. We grouped studies by comparator: a regimen containing dihydroergotamine, antiemetic alone, or ketorolac. For each study, we calculated an odds ratio (OR) of headache relief and then assessed clinical and statistical heterogeneity for the group of studies. We then pooled the ORs of headache relief with a random-effects model.

Results
From 899 citations, 19 clinical trials were identified, of which 11 were appropriate and had available data. Four trials involving 254 patients compared meperidine to dihydroergotamine, 4 trials involving 248 patients compared meperidine to an antiemetic, and 3 trials involving 123 patients compared meperidine to ketorolac. Meperidine was less effective than dihydroergotamine at providing headache relief (OR=0.30; 95% confidence interval [CI] 0.09 to 0.97) and trended toward less efficacy than the antiemetics (OR=0.46; 95% CI 0.19 to 1.11); however, the efficacy of meperidine was similar to that of ketorolac (OR=1.75; 95% CI 0.84 to 3.61). Compared to dihydroergotamine, meperidine caused more sedation (OR=3.52; 95% CI 0.87 to 14.19) and dizziness (OR=8.67; 95% CI 2.66 to 28.23). Compared to the antiemetics, meperidine caused less akathisia (OR=0.10; 95% CI 0.02 to 0.57). Meperidine and ketorolac use resulted in similar rates of gastrointestinal adverse effects (OR=1.27; 95% CI 0.31 to 5.15) and sedation (OR=1.70; 95% CI 0.23 to 12.72).

Conclusion
Clinicians should consider alternatives to meperidine when treating acute migraine with injectable agents.

18. Reversal of Profound Rocuronium-induced Blockade with Sugammadex: A Randomized Comparison with Neostigmine

Jones RK, et al. Anesthesiology. 2008;109:816-824.

Profound neuromuscular blockade reversal with 4 mg/kg sugammadex administered at 1-2 posttetanic counts after rocuronium is approximately 17 times faster than after 70 μg/kg neostigmine. Sugammadex may have unique ability to reverse profound neuromuscular blockade.

Abstract: http://www.anesthesiology.org/pt/re/anes/abstract.00000542-200811000-00014.htm

19. Aspirin for prevention of cardiovascular events is only effective in established cardiovascular disease

Hiatt WR. BMJ 2008;337:a1806

In the linked randomised controlled trial (doi:10.1136/bmj.a1840), Belch and colleagues assess whether aspirin and antioxidants, given together or separately, reduce cardiovascular events in patients with diabetes mellitus and asymptomatic peripheral arterial disease.

The use of aspirin for secondary prevention of cardiovascular events in patients with coronary or cerebrovascular disease is well established and is based on extensive evidence from the Antithrombotic Trialists’ Collaboration. That meta-analysis found that aspirin was beneficial in patients with acute myocardial infarction or ischaemic stroke; unstable or stable angina; and those with previous myocardial infarction, stroke, or cerebral ischaemia. However, not all patients with cardiovascular disease respond to aspirin, as shown by a recent meta-analysis of aspirin trials in peripheral artery disease.

In contrast, studies evaluating the possible benefits of aspirin for primary prevention in patients without cardiovascular disease have been consistently negative. A review by the United States Food and Drug Administration (FDA) of the proposed labelling of aspirin for primary prevention in 2003 evaluated five primary prevention trials and found that they were all negative for their primary end point. Further examination of those trials in the higher risk subgroups (Framingham risk score greater than 8-10% a decade) and in patients with diabetes also failed to show a benefit of aspirin. On the basis of this assessment, the FDA did not extend the labelling of aspirin for primary prevention.

Subsequent to the FDA meeting, the women’s health study—a randomised trial of 39 876 healthy women treated with aspirin or placebo—also failed to show a significant improvement for the primary end point (prevention of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes; P=0.13). But rather than emphasising this negative conclusion, the authors focused on a subgroup analysis that led them to conclude that aspirin reduced the risk of stroke in women.

The physicians’ health study randomised 22 071 healthy men to aspirin or placebo and found no benefit for the primary end point of cardiovascular mortality, although a subgroup analysis found that aspirin prevented non-fatal myocardial infarction in men. The major cardiovascular event rates in these two key primary prevention studies were less than 1% a year.

Despite the consistently negative evidence from trials, guidelines provide inconsistent recommendations on the use of aspirin to prevent cardiovascular events in healthy subjects at higher risk who do not have existing cardiovascular disease, particularly patients with diabetes. The assumption is that the positive findings of aspirin in patients with symptomatic coronary or cerebrovascular disease can be extrapolated to these high risk populations without clinical evidence of cardiovascular disease.

In this context, Belch and colleagues’ trial compared the effects of aspirin and antioxidants (using a factorial design) on the primary prevention of fatal and non-fatal major cardiovascular events in a high risk population. Patients were eligible if they had type 1 or type 2 diabetes and evidence of asymptomatic peripheral artery disease, defined by an ankle brachial index less than 1.00. More than 1200 patients were enrolled and followed up to eight years. At baseline, participants had a mean age of 60 years and an average ankle brachial index of 0.90. The observed risk of a major cardiovascular event was 2.9% a year, much higher that that seen in the previously noted primary prevention trials (driven by age of the population and the presence of diabetes and peripheral artery disease). Patients randomised to aspirin had 116 primary fatal and non-fatal cardiovascular events compared with 117 in the control group (hazard ratio 0.98, 95% confidence interval 0.76 to 1.26). No significant difference in major cardiovascular events was seen between the antioxidant treatment group and the placebo group. Although no significant difference was seen between the rate of gastrointestinal bleeding in each group, there was a trend for a greater incidence of gastrointestinal symptoms, including dyspepsia, in patients randomised to aspirin.

Belch and colleagues’ study supports the observations from six well conducted randomised control trials that found no benefit of aspirin for primary prevention, even in higher risk groups. The findings are also consistent with the previous report of no benefit of aspirin in patients with peripheral artery disease. What is striking about the negative effect of aspirin is that people in Belch and colleagues’ study were at particularly high risk given their age and the presence of diabetes and asymptomatic peripheral artery disease, with an event rate of about 3% a year.

These result support the concept that risk assessment alone cannot predict which patients will benefit from aspirin. In fact, the only predictor of clinical response to aspirin is a history of a major coronary or cerebral ischaemic event, as defined by the previous meta-analysis. The mechanisms of this differential response to aspirin are not known but clearly suggest that patients who respond to aspirin must have a history of clinical, symptomatic cardiovascular disease. This is in sharp contrast to the evidence that statins, for reducing concentrations of low density lipoprotein cholesterol, and drugs for treating hypertension have clinical benefit that extends to all risk groups, including those with and without cardiovascular disease. In these examples, the difference between primary and secondary prevention is only in the absolute reduction in risk because primary prevention populations have a lower absolute risk of cardiovascular events but receive the same relative benefit from the treatment.

A total of seven well controlled trials now show that aspirin has no benefit for primary prevention of cardiovascular events, even in people at higher risk. Although aspirin is cheap and universally available, practitioners and authors of guidelines need to heed the evidence that aspirin should be prescribed only in patients with established symptomatic cardiovascular disease.

20. Head Injury Policy Statement by the American College of Emergency Physicians

Abstract
This clinical policy provides evidence-based recommendations on select issues in the management of adult patients with mild traumatic brain injury (TBI) in the acute setting. It is the result of joint efforts between the American College of Emergency Physicians and the Centers for Disease Control and Prevention and was developed by a multidisciplinary panel. The critical questions addressed in this clinical policy are:

(1) Which patients with mild TBI should have a noncontrast head computed tomography (CT) scan in the emergency department (ED)?
(2) Is there a role for head magnetic resonance imaging over noncontrast CT in the ED evaluation of a patient with acute mild TBI?
(3) In patients with mild TBI, are brain specific serum biomarkers predictive of an acute traumatic intracranial injury?
(4) Can a patient with an isolated mild TBI and a normal neurologic evaluation result be safely discharged from the ED if a noncontrast head CT scan shows no evidence of intracranial injury? Inclusion criteria for application of this clinical policy's recommendations are nonpenetrating trauma to the head, presentation to the ED within 24 hours of injury, a Glasgow Coma Scale score of 14 or 15 on initial evaluation in the ED, and aged 16 years or greater. The primary outcome measure for questions 1, 2, and 3 is the presence of an acute intracranial injury on noncontrast head CT scan; the primary outcome measure for question 4 is the occurrence of neurologic deterioration.

Full-text: http://www.acep.org/workarea/downloadasset.aspx?id=8814