From Medscape Pediatrics > Viewpoints
William T. Basco, Jr., MD
A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media
Tähtinen P, Laine MK, Huovinen P, Jalava J, Ruuskanen O, Ruohala A
N Engl J Med. 2011;364:116-126
Study Summary
Tähtinen and coworkers evaluated the efficacy of antibiotic treatment for acute otitis media (AOM) in a group of Finnish children 6-35 months old. Children were generally healthy and met 3 criteria for diagnosis of AOM:
* Middle ear fluid detected by pneumatic otoscopy as evidenced by at least 2 of the following: a bulging tympanic membrane, decreased mobility of the tympanic membrane, abnormal color or opacity (not due to scarring), or air-fluid levels;
* Erythema of the tympanic membrane; and
* Presence of acute symptoms, such as fever, ear pain, or respiratory symptoms.
The study was a randomized, double-blind, placebo-controlled trial not sponsored by a pharmaceutical group.
The study drug was amoxicillin-clavulanate, dosed at 40 mg/kg/day (amoxicillin component) and given over 7 days.
The placebo preparation had similar taste and color.
Parents recorded daily symptoms, drug administration, missed school or daycare, missed parental work, and adverse events associated with taking the medication.
Parents were allowed to administer oral analgesics and antipyretics along with analgesic ear drops and decongestant nose drops or sprays.
Enrollment day was day 1, and follow-up visits took place on day 3 and day 8, the end of treatment.
Parents were to contact the investigators at any time if their child's condition worsened.
Study physicians were allowed to switch children to a rescue preparation if deemed necessary during a follow-up visit.
The primary outcome was time to treatment failure.
Treatment failure could be evidenced by one of the following criteria:
* Failure to improve by day 3;
* Worsening overall condition at any point;
* Worsening otoscopic findings;
* Perforation of the tympanic membrane;
* Development of a complication of AOM, such as mastoiditis; and
* Parental discontinuation of the study drug for any reason.
A total of 319 children were enrolled in the study, 161 of whom received the active compound and 158 of whom received placebo.
The mean age of the children was 3 years, and the groups did not differ in frequency of previous AOM, receipt of vaccines, or current symptoms.
Children who received placebo were more likely to be afebrile (70.9% vs 60.2%) compared with children who assigned to the intervention arm.
Study children had 94% adherence to study medication administration.
Overall, treatment failure was much higher in the placebo group (44.9%) than in the intervention group (18.6%, P < .001).
This difference between groups was already apparent at the day 3 visit.
Treatment with study compound resulted in a 62% reduction in the risk for treatment failure (95% confidence interval, 0.25-0.59).
The number needed to treat to avoid 1 treatment failure was 3.8 children.
Each of the independent contributors to "treatment failure" occurred less frequently in the treatment group than in the placebo group.
Rescue treatment was administered to 6.8% of intervention-arm children and 33.5% of placebo-arm children.
No differences in use of analgesics or antipyretics were found between the groups.
Treatment-arm children missed fewer daycare and the parents of these children missed fewer work days; both differences were significant.
Diarrhea, the most common adverse event, was almost twice as common in the treatment group (47.8% vs 26.6%), but none of the treatment-group children stopped antibiotics because of diarrhea.
The investigators concluded that amoxicillin-clavulanate was superior to placebo for the treatment of AOM.
Abstract
Wednesday, March 30, 2011
Monday, March 14, 2011
Nuclear and Radiologic Decontamination
eMedicine Specialties > Emergency Medicine > Warfare - Chemical, Biological, Radiological, Nuclear and Explosives
Author: Scott D Weingart, MD, Assistant Clinical Professor and Director, Division of Emergency Department Critical Care, Department of Emergency Medicine, Mount Sinai School of Medicine
Coauthor(s): Ben R Maltz, MD, State Surgeon, Washington Army National Guard, Science Officer, 10th Civil Support Team (Weapons of Mass Destruction)
Updated: Mar 9, 2009
In light of the events of September 11, 2002, terrorist attack has moved to the forefront of emergency department (ED) and Emergency Medical Services (EMS) planning. The use of radiologic weaponry is one threat that must be considered. In addition to attack by terrorists, preparations must also be made for a nuclear power plant disaster or contamination by radiologic medical sources. In the event of radiologic contamination, rapid treatment can be lifesaving.
Properly completed, rapid decontamination can reduce morbidity and mortality, limit the spread of contamination, and keep the ED functioning for the treatment of other patients.
For related information, see CBRNE - Radiation Emergencies. For excellent patient education resources, visit eMedicine's Bioterrorism and Warfare Center. Also, see eMedicine's patient education article Chemical Warfare.
Recognition of Contamination
The first step of recognizing contamination is to understand the difference between exposure to and contamination by radiologic agents.
Exposure is defined by an individual's proximity to material emitting ionizing radiation.
Actually touching, inhaling, or swallowing that material is contamination.1
A useful analogy is to imagine a person sitting around a campfire. By merely sitting next to the fire, the individual is exposed to the heat. If the person sits close enough to the fire, he or she might even get burned; however, as soon as the person is removed from the proximity of the fire, he or she would certainly not burn anyone else. If the person falls into the fire, in addition to being burned, he or she becomes covered in ash. This is external contamination. If other people touch the individual who fell into the fire, they would get ash on their hands, spreading the contamination. In the course of falling into the fire, if the individual swallowed, inhaled, or absorbed any of the ashes through cut skin, he or she would be internally contaminated as well.
Personal Protective Equipment
For an isolated radiologic incident, level D personal protective equipment (PPE) is all that is required. Level D PPE consists of surgical gown, mask, and latex gloves (universal precautions). If airborne contamination is a possibility, the use of a fitted air-purifying respirator (N95 or 100 filter mask) increases protection. Eye protection should also be worn to prevent ocular contamination from any splashing during the decontamination procedure. If any possibility of mixed exposure exists, higher levels of PPE may be required as dictated by the chemical or biological agents involved (see CBRNE - Personal Protective Equipment). Local and state laws, facility protocols, and Occupational Safety and Health Administration (OSHA) regulations must be followed.2,3
Shielding devices that are normally used for radiology studies are not recommended for radiologic decontamination. These devices, such as lead aprons, were designed to block low-energy radionuclides and are not effective shields for the high-energy emissions present in most decontamination situations. In addition, their bulk hinders the decontamination process and therefore leads to an increased exposure time.
Shielding capacity is limited in the hospital environment. However, other factors may potentially limit exposure to those providing patient decontamination. These factors are time, distance, and quantity.
The longer the time spent in the contaminated environment, the greater the dose of radiation to the worker; therefore, a rotating team approach is advised. Doubling the distance from the radioactive source decreases the dose by a factor of 4. Likewise, limiting the quantity of radioactive items in the decontamination area is advisable.
External Decontamination
The process of external decontamination can be divided into 2 stages: gross decontamination and secondary decontamination.
Gross decontamination
Gross decontamination is usually performed before the patient reaches a hospital environment. It consists of removal of all the patient's clothing and, if possible, brief irrigation of the patient's entire body with water. Clothing should be removed with a careful "roll-down" method to prevent inhalation of airborne particulates. If the patient is contaminated solely by a radiologic source, water is sufficient for the washing. If a possibility of mixed contamination exists, the protocols for biologic and/or chemical decontamination should be used because these regimens are more extensive than those used for radiologic decontamination. Since most radiologic contamination is located on the head and hands, the patient should be in the "head-back" position during initial showering to prevent run-off into the eyes, nose, or mouth. Early handwashing is also important.
Gross decontamination removes more than 95% of external contamination and renders the patient safe for access by care providers.1 If gross decontamination has not occurred in the field, it must be performed by ED personnel in a designated decontamination site. In most centers, the decontamination site is outside and immediately adjacent to the ED. The small amount of radioactivity present in the irrigation runoff produces minimal risk to the communal water supply or groundwater; therefore, patient decontamination should not be delayed by attempts to contain run-off. However, facility protocols and local, state, and federal laws should always be followed. After gross decontamination, the patient should be wrapped in a sheet for transport into the ED.
If the patient requiring decontamination becomes medically unstable at any point during the process, provision of medical care should take precedence over decontamination. The risk to care providers when treating a patient with radiologic contamination is virtually nil. If available, a radiation survey meter can be used to identify the extremely rare case of a patient who is emitting an amount of radiation sufficient to cause concern.
In the event of a mass casualty incident, gross decontamination is all that is immediately necessary. Patients should disrobe, with assistance if necessary. If able to ambulate, patients can briefly shower in a decontamination area. Likewise, the decontamination team needs only water to briefly wash patients who are unable to shower themselves. At this point, patients are sufficiently decontaminated and can receive treatment of any medical problems. Secondary decontamination of these patients can be postponed until more resources are available.
Secondary decontamination
Secondary decontamination is a stepwise methodical cleansing of any remaining radioactive areas of the patient. It should be performed under the guidance of the hospital's Radiation Safety Officer (RSO) or another member of the team trained in the use of radiation detection devices (RDD), such as a radiac instrument.
An area in the ED should be set aside for the decontamination procedure. Because this area may be out of service for a significant period, a location should be chosen that would not interrupt the normal workings of the department. A path to the decontamination room should be made with paper floor coverings and clear barriers to prevent the spread of contamination. In addition, these barriers prevent the entrance of extraneous personnel and visitors.
A decontamination team customarily consists of the RSO and two assistants, one of whom may be a clinician. However, in a mass-casualty setting, clinicians will likely not be available to perform decontamination. All members of the team should change out of their normal clothing into attire that can be bagged after the procedure. Shoe coverings, surgical masks, and eye protection should also be worn. Each member should be issued a dosimeter, which is a device that passively measures exposure to radioisotopes.
The general procedure for secondary decontamination involves using an RDD to perform a head-to-toe survey of all areas of the patient's body. Further irrigation is required for any areas with readings above the threshold, which is determined by the RSO on the basis of the RDD calibration. All secretions and runoff should be collected for sampling and dose estimation. After irrigation, the areas are surveyed again. This process is continued until acceptable levels are reached. Acceptable levels may be slightly above baseline and should be determined by the RSO and treating physicians.
Certain areas of the body require special procedures, as follows:2
* Mouth: Remove and bag any dentures, loose dental work, or foreign bodies. Take swab samples from the oral cavity. Preferable sites for swabs are under the tongue and between gums and teeth. The patient or physician should gently brush the teeth, gums, and tongue, being careful to avoid irritating the gums and causing bleeding. The mouth should then be copiously rinsed, taking care to avoid swallowing the rinse water. Resample with the RDD as above.
* Nose: Obtain nasal swabs. The patient should then gently blow his or her nose. Irrigate the nares while the patient leans forward, taking care to prevent the irrigating solution from being swallowed or aspirated.
* Eyes: If no contraindications exist, anesthetize the eyes with a topical agent. Sample the conjunctiva with moistened swabs, and copiously irrigate with saline. This can be facilitated with commercial eye irrigation devices, or a nasal canula attached to an intravenous (IV) bag can be used as an improvised eye irrigation system. If irrigating manually, irrigate medial to lateral with the patient's head turned to the side to minimize contamination of the lacrimal duct.
* Ears: Take samples from the external canals with moistened swabs. Examine the tympanic membranes for perforation, especially after blast incidents. If no perforation is found, copiously irrigate the canals with saline warmed to body temperature.
* Open wounds: Obtain wound swabs. If any particulate matter or foreign bodies are present, they should be removed and saved. Copiously irrigate the area and resurvey as in intact skin. Cover the wound with waterproof dressing to avoid recontamination from the run-off from irrigating other areas.
Internal Decontamination
Internal decontamination can be achieved by a number of methods, including the blockade of enteral absorption, blockade of end-organ uptake, dilution, and chelation. Speed is of the essence because some isotopes can be incorporated by end organs within an hour of exposure and are very difficult to remove. Therefore, EDs that are expected to care for these individuals must have the resources for internal decontamination available.
Blockade of enteral absorption
Gastric lavage and emetic agents: Although these strategies may decrease absorption of radioisotopes if initiated early after gastric contamination, they also create the risk of aspiration of radioisotopes, leading to respiratory contamination. No studies using gastric lavage or emetic agents for radiologic decontamination have been performed. However, a comparison can possibly be made with toxicologic exposures in which there are few recommended uses for these procedures. The authors currently do not recommend the routine use of gastric lavage or emetic agents.
Enteral binding methods: Some enteral binding methods have been shown to effectively bind specific agents of contamination.4,2
* Barium sulfate: This drug, which is commonly used for radiographic contrast studies, forms irreversible bonds with strontium and radium, which are used in older military, industrial, and medical equipment. Once bound, these agents pass through the gastrointestinal tract unabsorbed. A 1-time dose of 200 mL of 100% barium sulfate should be administered for internal decontamination.
* Aluminum and magnesium salts: Commercially available in agents such as Maalox and Mylanta, these salts bind to and reduce the absorption of strontium, radium, and phosphorus in a manner similar to barium sulfate. A dose of 100 mL of either of these agents should be given by mouth or nasogastric tube as soon as possible after exposure.
* Prussian blue: This agent binds to and increases the elimination of cesium and thallium. Cesium is found in medical radiotherapy devices and was used by terrorists in Russia during an attempted attack; thallium is used in medical imaging. Prussian blue also blocks the absorption of rubidium. If internal contamination with one of these agents is present, administer 1 g by mouth tid for 3 weeks. This medication has recently received FDA approval under the name Radiogardase.
* Activated charcoal: In patients without a decreased level of consciousness, the administration of one dose of activated charcoal may bind to and speed the elimination of some radioisotopes. Because the adverse effects of this medication are rare, activated charcoal is recommended if administered shortly after exposure. A dose of 50-100 g should be given by mouth or gastric tube; if the patient is at risk for aspiration, this medication should be avoided.
Blockade of end-organ uptake
Potassium iodide (KI): This medication has recently received much attention by the press. It is viewed by the public as a universal blocking agent for all the effects of a radiologic or nuclear attack. Radioactive iodine (RAI) is present in nuclear reactor fuel rods; therefore, in the event of any reactor accident, terrorist attack, or use of fuel rods for terrorist explosive devices (radiation dispersal devices, ie, dirty bombs), RAI can be released. The primary toxicity of RAI is to the thyroid gland. Competitive blockade of RAI and technetium uptake can be achieved with large doses of KI. Effectiveness is directly proportional to the speed of administration, which is preferably within 6 hours of exposure. Toxicity of RAI is highest in the pediatric population, but this medication should be administered to any patient who has been contaminated. The dose is 300 mg/d by mouth for 1-2 weeks.
Calcium: Calcium gluconate or calcium chloride can be administered to limit the incorporation of strontium or radioactive calcium into bone. Patients can receive 1 g of calcium chloride or 3 g of calcium gluconate administered intravenously.
Dilution
Oral fluids: Tritium is present in nuclear weapons and is used by the military for luminescent gun sights. If internal contamination with tritium is suspected, administer copious oral or intravenous fluids to cause dilution and increase renal excretion of tritiated water. Oral fluid in the amount of 5-10 L/d should be administered for 1 week. Sodium monitoring is necessary if hypotonic fluids are used.
Phosphorus: Similar to dilution of tritium, oral loading with phosphorus salts (Neutra-Phos) can enhance the elimination of radioactive phosphorus. One packet of Neutra Phos or 2 tablets of K Phos should be administered qid by mouth for 3 days.
Chelation
Diethylenetriamine pentaacetic acid (DTPA): Americium (a daughter product of plutonium), uranium, plutonium, and other heavy metals (present in nuclear reactors and weapons) are poorly excreted by the kidneys. Pentetate calcium trisodium (CaDTPA) and pentetate zinc trisodium (ZnDTPA) form compounds with specific radioisotopes (ie, americium, curium, plutonium), rendering them more easily excreted by the kidneys and enhancing elimination. These drugs were recently FDA approved. The Oak Ridge Institute of Science and Education has given DTPA IND status. Immediately contact REAC/TS in the event of a contamination (see Obtaining Expert Advice).
If within the first 24 hours of exposure, use Ca-DTPA. For subsequent doses, or if first treating after 24 hours of exposure, use Zn-DTPA. The dose for either agent is 1 g dissolved in 250 mL of saline or D5W given over 1 hour qd. If the exposure is solely respiratory, 1 g of either agent can be mixed 1:1 with normal saline and nebulized.
Penicillamine: Radioactive cobalt is used for medical radiotherapy and food irradiation. In the case of internal contamination caused by radioactive cobalt, similar clinical effects to DTPA administration can be achieved with the use of penicillamine. The dose is 250-500 mg by mouth 4 times per day.
Decrease organ damage
Sodium bicarbonate: Depleted uranium is found in reactor fuel rods and nuclear weapons. It can cause acute tubular necrosis (ATN) and renal failure in cases of internal contamination. The alkalinization provided by sodium bicarbonate makes the uranium less nephrotoxic. Administer an initial bolus of 2 mEq/kg intravenously. Then add 4 ampules to 1 L of D5W and titrated to a urinary pH of 6.5-7.5. (Urinary acidification has been proposed to enhance the elimination of strontium.)
Wound excision
Wound excision may be considered when the wound is contaminated with an isotope that has a very long half-life, such as plutonium.
Obtaining Expert Advice
The treatment of patients with internal contamination involves complicated diagnostic and therapeutic regimens. In addition to the local poison center (nationwide number, 1-800-222-1222), one of the following agencies should be contacted for guidance as soon as possible.
* Armed Forces Radiobiology Research Institute (AFRRI) Web site; telephone, (301) 295-0530
* Radiation Emergency Assistance Center/Training Site (REAC/TS) Web site; telephone, (865) 576-1005 (ask for REAC/TS)
Author: Scott D Weingart, MD, Assistant Clinical Professor and Director, Division of Emergency Department Critical Care, Department of Emergency Medicine, Mount Sinai School of Medicine
Coauthor(s): Ben R Maltz, MD, State Surgeon, Washington Army National Guard, Science Officer, 10th Civil Support Team (Weapons of Mass Destruction)
Updated: Mar 9, 2009
In light of the events of September 11, 2002, terrorist attack has moved to the forefront of emergency department (ED) and Emergency Medical Services (EMS) planning. The use of radiologic weaponry is one threat that must be considered. In addition to attack by terrorists, preparations must also be made for a nuclear power plant disaster or contamination by radiologic medical sources. In the event of radiologic contamination, rapid treatment can be lifesaving.
Properly completed, rapid decontamination can reduce morbidity and mortality, limit the spread of contamination, and keep the ED functioning for the treatment of other patients.
For related information, see CBRNE - Radiation Emergencies. For excellent patient education resources, visit eMedicine's Bioterrorism and Warfare Center. Also, see eMedicine's patient education article Chemical Warfare.
Recognition of Contamination
The first step of recognizing contamination is to understand the difference between exposure to and contamination by radiologic agents.
Exposure is defined by an individual's proximity to material emitting ionizing radiation.
Actually touching, inhaling, or swallowing that material is contamination.1
A useful analogy is to imagine a person sitting around a campfire. By merely sitting next to the fire, the individual is exposed to the heat. If the person sits close enough to the fire, he or she might even get burned; however, as soon as the person is removed from the proximity of the fire, he or she would certainly not burn anyone else. If the person falls into the fire, in addition to being burned, he or she becomes covered in ash. This is external contamination. If other people touch the individual who fell into the fire, they would get ash on their hands, spreading the contamination. In the course of falling into the fire, if the individual swallowed, inhaled, or absorbed any of the ashes through cut skin, he or she would be internally contaminated as well.
Personal Protective Equipment
For an isolated radiologic incident, level D personal protective equipment (PPE) is all that is required. Level D PPE consists of surgical gown, mask, and latex gloves (universal precautions). If airborne contamination is a possibility, the use of a fitted air-purifying respirator (N95 or 100 filter mask) increases protection. Eye protection should also be worn to prevent ocular contamination from any splashing during the decontamination procedure. If any possibility of mixed exposure exists, higher levels of PPE may be required as dictated by the chemical or biological agents involved (see CBRNE - Personal Protective Equipment). Local and state laws, facility protocols, and Occupational Safety and Health Administration (OSHA) regulations must be followed.2,3
Shielding devices that are normally used for radiology studies are not recommended for radiologic decontamination. These devices, such as lead aprons, were designed to block low-energy radionuclides and are not effective shields for the high-energy emissions present in most decontamination situations. In addition, their bulk hinders the decontamination process and therefore leads to an increased exposure time.
Shielding capacity is limited in the hospital environment. However, other factors may potentially limit exposure to those providing patient decontamination. These factors are time, distance, and quantity.
The longer the time spent in the contaminated environment, the greater the dose of radiation to the worker; therefore, a rotating team approach is advised. Doubling the distance from the radioactive source decreases the dose by a factor of 4. Likewise, limiting the quantity of radioactive items in the decontamination area is advisable.
External Decontamination
The process of external decontamination can be divided into 2 stages: gross decontamination and secondary decontamination.
Gross decontamination
Gross decontamination is usually performed before the patient reaches a hospital environment. It consists of removal of all the patient's clothing and, if possible, brief irrigation of the patient's entire body with water. Clothing should be removed with a careful "roll-down" method to prevent inhalation of airborne particulates. If the patient is contaminated solely by a radiologic source, water is sufficient for the washing. If a possibility of mixed contamination exists, the protocols for biologic and/or chemical decontamination should be used because these regimens are more extensive than those used for radiologic decontamination. Since most radiologic contamination is located on the head and hands, the patient should be in the "head-back" position during initial showering to prevent run-off into the eyes, nose, or mouth. Early handwashing is also important.
Gross decontamination removes more than 95% of external contamination and renders the patient safe for access by care providers.1 If gross decontamination has not occurred in the field, it must be performed by ED personnel in a designated decontamination site. In most centers, the decontamination site is outside and immediately adjacent to the ED. The small amount of radioactivity present in the irrigation runoff produces minimal risk to the communal water supply or groundwater; therefore, patient decontamination should not be delayed by attempts to contain run-off. However, facility protocols and local, state, and federal laws should always be followed. After gross decontamination, the patient should be wrapped in a sheet for transport into the ED.
If the patient requiring decontamination becomes medically unstable at any point during the process, provision of medical care should take precedence over decontamination. The risk to care providers when treating a patient with radiologic contamination is virtually nil. If available, a radiation survey meter can be used to identify the extremely rare case of a patient who is emitting an amount of radiation sufficient to cause concern.
In the event of a mass casualty incident, gross decontamination is all that is immediately necessary. Patients should disrobe, with assistance if necessary. If able to ambulate, patients can briefly shower in a decontamination area. Likewise, the decontamination team needs only water to briefly wash patients who are unable to shower themselves. At this point, patients are sufficiently decontaminated and can receive treatment of any medical problems. Secondary decontamination of these patients can be postponed until more resources are available.
Secondary decontamination
Secondary decontamination is a stepwise methodical cleansing of any remaining radioactive areas of the patient. It should be performed under the guidance of the hospital's Radiation Safety Officer (RSO) or another member of the team trained in the use of radiation detection devices (RDD), such as a radiac instrument.
An area in the ED should be set aside for the decontamination procedure. Because this area may be out of service for a significant period, a location should be chosen that would not interrupt the normal workings of the department. A path to the decontamination room should be made with paper floor coverings and clear barriers to prevent the spread of contamination. In addition, these barriers prevent the entrance of extraneous personnel and visitors.
A decontamination team customarily consists of the RSO and two assistants, one of whom may be a clinician. However, in a mass-casualty setting, clinicians will likely not be available to perform decontamination. All members of the team should change out of their normal clothing into attire that can be bagged after the procedure. Shoe coverings, surgical masks, and eye protection should also be worn. Each member should be issued a dosimeter, which is a device that passively measures exposure to radioisotopes.
The general procedure for secondary decontamination involves using an RDD to perform a head-to-toe survey of all areas of the patient's body. Further irrigation is required for any areas with readings above the threshold, which is determined by the RSO on the basis of the RDD calibration. All secretions and runoff should be collected for sampling and dose estimation. After irrigation, the areas are surveyed again. This process is continued until acceptable levels are reached. Acceptable levels may be slightly above baseline and should be determined by the RSO and treating physicians.
Certain areas of the body require special procedures, as follows:2
* Mouth: Remove and bag any dentures, loose dental work, or foreign bodies. Take swab samples from the oral cavity. Preferable sites for swabs are under the tongue and between gums and teeth. The patient or physician should gently brush the teeth, gums, and tongue, being careful to avoid irritating the gums and causing bleeding. The mouth should then be copiously rinsed, taking care to avoid swallowing the rinse water. Resample with the RDD as above.
* Nose: Obtain nasal swabs. The patient should then gently blow his or her nose. Irrigate the nares while the patient leans forward, taking care to prevent the irrigating solution from being swallowed or aspirated.
* Eyes: If no contraindications exist, anesthetize the eyes with a topical agent. Sample the conjunctiva with moistened swabs, and copiously irrigate with saline. This can be facilitated with commercial eye irrigation devices, or a nasal canula attached to an intravenous (IV) bag can be used as an improvised eye irrigation system. If irrigating manually, irrigate medial to lateral with the patient's head turned to the side to minimize contamination of the lacrimal duct.
* Ears: Take samples from the external canals with moistened swabs. Examine the tympanic membranes for perforation, especially after blast incidents. If no perforation is found, copiously irrigate the canals with saline warmed to body temperature.
* Open wounds: Obtain wound swabs. If any particulate matter or foreign bodies are present, they should be removed and saved. Copiously irrigate the area and resurvey as in intact skin. Cover the wound with waterproof dressing to avoid recontamination from the run-off from irrigating other areas.
Internal Decontamination
Internal decontamination can be achieved by a number of methods, including the blockade of enteral absorption, blockade of end-organ uptake, dilution, and chelation. Speed is of the essence because some isotopes can be incorporated by end organs within an hour of exposure and are very difficult to remove. Therefore, EDs that are expected to care for these individuals must have the resources for internal decontamination available.
Blockade of enteral absorption
Gastric lavage and emetic agents: Although these strategies may decrease absorption of radioisotopes if initiated early after gastric contamination, they also create the risk of aspiration of radioisotopes, leading to respiratory contamination. No studies using gastric lavage or emetic agents for radiologic decontamination have been performed. However, a comparison can possibly be made with toxicologic exposures in which there are few recommended uses for these procedures. The authors currently do not recommend the routine use of gastric lavage or emetic agents.
Enteral binding methods: Some enteral binding methods have been shown to effectively bind specific agents of contamination.4,2
* Barium sulfate: This drug, which is commonly used for radiographic contrast studies, forms irreversible bonds with strontium and radium, which are used in older military, industrial, and medical equipment. Once bound, these agents pass through the gastrointestinal tract unabsorbed. A 1-time dose of 200 mL of 100% barium sulfate should be administered for internal decontamination.
* Aluminum and magnesium salts: Commercially available in agents such as Maalox and Mylanta, these salts bind to and reduce the absorption of strontium, radium, and phosphorus in a manner similar to barium sulfate. A dose of 100 mL of either of these agents should be given by mouth or nasogastric tube as soon as possible after exposure.
* Prussian blue: This agent binds to and increases the elimination of cesium and thallium. Cesium is found in medical radiotherapy devices and was used by terrorists in Russia during an attempted attack; thallium is used in medical imaging. Prussian blue also blocks the absorption of rubidium. If internal contamination with one of these agents is present, administer 1 g by mouth tid for 3 weeks. This medication has recently received FDA approval under the name Radiogardase.
* Activated charcoal: In patients without a decreased level of consciousness, the administration of one dose of activated charcoal may bind to and speed the elimination of some radioisotopes. Because the adverse effects of this medication are rare, activated charcoal is recommended if administered shortly after exposure. A dose of 50-100 g should be given by mouth or gastric tube; if the patient is at risk for aspiration, this medication should be avoided.
Blockade of end-organ uptake
Potassium iodide (KI): This medication has recently received much attention by the press. It is viewed by the public as a universal blocking agent for all the effects of a radiologic or nuclear attack. Radioactive iodine (RAI) is present in nuclear reactor fuel rods; therefore, in the event of any reactor accident, terrorist attack, or use of fuel rods for terrorist explosive devices (radiation dispersal devices, ie, dirty bombs), RAI can be released. The primary toxicity of RAI is to the thyroid gland. Competitive blockade of RAI and technetium uptake can be achieved with large doses of KI. Effectiveness is directly proportional to the speed of administration, which is preferably within 6 hours of exposure. Toxicity of RAI is highest in the pediatric population, but this medication should be administered to any patient who has been contaminated. The dose is 300 mg/d by mouth for 1-2 weeks.
Calcium: Calcium gluconate or calcium chloride can be administered to limit the incorporation of strontium or radioactive calcium into bone. Patients can receive 1 g of calcium chloride or 3 g of calcium gluconate administered intravenously.
Dilution
Oral fluids: Tritium is present in nuclear weapons and is used by the military for luminescent gun sights. If internal contamination with tritium is suspected, administer copious oral or intravenous fluids to cause dilution and increase renal excretion of tritiated water. Oral fluid in the amount of 5-10 L/d should be administered for 1 week. Sodium monitoring is necessary if hypotonic fluids are used.
Phosphorus: Similar to dilution of tritium, oral loading with phosphorus salts (Neutra-Phos) can enhance the elimination of radioactive phosphorus. One packet of Neutra Phos or 2 tablets of K Phos should be administered qid by mouth for 3 days.
Chelation
Diethylenetriamine pentaacetic acid (DTPA): Americium (a daughter product of plutonium), uranium, plutonium, and other heavy metals (present in nuclear reactors and weapons) are poorly excreted by the kidneys. Pentetate calcium trisodium (CaDTPA) and pentetate zinc trisodium (ZnDTPA) form compounds with specific radioisotopes (ie, americium, curium, plutonium), rendering them more easily excreted by the kidneys and enhancing elimination. These drugs were recently FDA approved. The Oak Ridge Institute of Science and Education has given DTPA IND status. Immediately contact REAC/TS in the event of a contamination (see Obtaining Expert Advice).
If within the first 24 hours of exposure, use Ca-DTPA. For subsequent doses, or if first treating after 24 hours of exposure, use Zn-DTPA. The dose for either agent is 1 g dissolved in 250 mL of saline or D5W given over 1 hour qd. If the exposure is solely respiratory, 1 g of either agent can be mixed 1:1 with normal saline and nebulized.
Penicillamine: Radioactive cobalt is used for medical radiotherapy and food irradiation. In the case of internal contamination caused by radioactive cobalt, similar clinical effects to DTPA administration can be achieved with the use of penicillamine. The dose is 250-500 mg by mouth 4 times per day.
Decrease organ damage
Sodium bicarbonate: Depleted uranium is found in reactor fuel rods and nuclear weapons. It can cause acute tubular necrosis (ATN) and renal failure in cases of internal contamination. The alkalinization provided by sodium bicarbonate makes the uranium less nephrotoxic. Administer an initial bolus of 2 mEq/kg intravenously. Then add 4 ampules to 1 L of D5W and titrated to a urinary pH of 6.5-7.5. (Urinary acidification has been proposed to enhance the elimination of strontium.)
Wound excision
Wound excision may be considered when the wound is contaminated with an isotope that has a very long half-life, such as plutonium.
Obtaining Expert Advice
The treatment of patients with internal contamination involves complicated diagnostic and therapeutic regimens. In addition to the local poison center (nationwide number, 1-800-222-1222), one of the following agencies should be contacted for guidance as soon as possible.
* Armed Forces Radiobiology Research Institute (AFRRI) Web site; telephone, (301) 295-0530
* Radiation Emergency Assistance Center/Training Site (REAC/TS) Web site; telephone, (865) 576-1005 (ask for REAC/TS)
Wednesday, March 9, 2011
A1C versus Glucose Testing: A Comparison
From Diabetes Care
David B. Sacks, MB; CHB; FRCPATH
Posted: 03/02/2011; Diabetes Care. 2011;34(2) © 2011 American Diabetes Association, Inc.
Introduction
Diabetes was originally identified by the presence of glucose in the urine.
Almost 2,500 years ago it was noticed that ants were attracted to the urine of some individuals. In the 18th and 19th centuries the sweet taste of urine was used for diagnosis before chemical methods became available to detect sugars in the urine. Tests to measure glucose in the blood were developed over 100 years ago, and hyperglycemia subsequently became the sole criterion recommended for the diagnosis of diabetes.
Initial diagnostic criteria relied on the response to an oral glucose challenge, while later measurement of blood glucose in an individual who was fasting also became acceptable.
The most widely accepted glucose-based criteria for diagnosis are fasting plasma glucose (FPG) ≥126 mg/dL or a 2-h plasma glucose ≥200 mg/dL during an oral glucose tolerance test (OGTT) on more than one occasion.[1,2]
In a patient with classic symptoms of diabetes, a single random plasma glucose ≥200 mg/dL is considered diagnostic.
Before 2010 virtually all diabetes societies recommended blood glucose analysis as the exclusive method to diagnose diabetes.
Notwithstanding these guidelines, over the last few years many physicians have been using hemoglobin A1C to screen for and diagnose diabetes.
Although considered the "gold standard" for diagnosis, measurement of glucose in the blood is subject to several limitations, many of which are not widely appreciated. Measurement of A1C for diagnosis is appealing but has some inherent limitations. These issues have become the focus of considerable attention with the recent publication of the Report of the International Expert Committee that recommended the use of A1C for diagnosis of diabetes, a position that has been endorsed (at the time of writing) by the American Diabetes Association (ADA), the Endocrine Society, and in a more limited fashion by American Association of Clinical Endocrinologists/American College of Endocrinology. This review will provide an overview of the factors that influence glucose and A1C testing.
Perspective
Notwithstanding the use of glucose (FPG and/or the OGTT) as the "gold standard" for the diagnosis of diabetes for many years, glucose testing suffers from several deficiencies. The requirement that the subject be fasting at the time the blood is drawn is a considerable inconvenience. While our ability to measure glucose has improved, inherent biological variability can produce very large differences within and among individuals. In conjunction with lack of sample stability, which is difficult to overcome in clinical practice, these factors results in lack of reproducibility of glucose testing.
A1C, which reflects chronic blood glucose values, is routinely used in monitoring glycemic control and guiding therapy. The significant reduction in microvascular complications with lower A1C and the absence of sample lability, combined with several other advantages (Table 3), have led to the recommendation by some organizations that A1C be used for screening and diagnosis of diabetes.
Accumulating evidence suggests that racial differences in A1C values may be present, and the possible clinical significance of this needs to be determined. Importantly, A1C cannot be measured in certain conditions. Despite these caveats, A1C can be measured accurately in the vast majority of people. A comprehension of the factors that influence A1C values and the conditions where it should not be used will produce accurate and clinically meaningful results.
The convenience of sampling at any time without regard to food ingestion makes it likely that measurement of A1C will result in the detection of many of the millions of people with diabetes who are currently undiagnosed.
David B. Sacks, MB; CHB; FRCPATH
Posted: 03/02/2011; Diabetes Care. 2011;34(2) © 2011 American Diabetes Association, Inc.
Introduction
Diabetes was originally identified by the presence of glucose in the urine.
Almost 2,500 years ago it was noticed that ants were attracted to the urine of some individuals. In the 18th and 19th centuries the sweet taste of urine was used for diagnosis before chemical methods became available to detect sugars in the urine. Tests to measure glucose in the blood were developed over 100 years ago, and hyperglycemia subsequently became the sole criterion recommended for the diagnosis of diabetes.
Initial diagnostic criteria relied on the response to an oral glucose challenge, while later measurement of blood glucose in an individual who was fasting also became acceptable.
The most widely accepted glucose-based criteria for diagnosis are fasting plasma glucose (FPG) ≥126 mg/dL or a 2-h plasma glucose ≥200 mg/dL during an oral glucose tolerance test (OGTT) on more than one occasion.[1,2]
In a patient with classic symptoms of diabetes, a single random plasma glucose ≥200 mg/dL is considered diagnostic.
Before 2010 virtually all diabetes societies recommended blood glucose analysis as the exclusive method to diagnose diabetes.
Notwithstanding these guidelines, over the last few years many physicians have been using hemoglobin A1C to screen for and diagnose diabetes.
Although considered the "gold standard" for diagnosis, measurement of glucose in the blood is subject to several limitations, many of which are not widely appreciated. Measurement of A1C for diagnosis is appealing but has some inherent limitations. These issues have become the focus of considerable attention with the recent publication of the Report of the International Expert Committee that recommended the use of A1C for diagnosis of diabetes, a position that has been endorsed (at the time of writing) by the American Diabetes Association (ADA), the Endocrine Society, and in a more limited fashion by American Association of Clinical Endocrinologists/American College of Endocrinology. This review will provide an overview of the factors that influence glucose and A1C testing.
Perspective
Notwithstanding the use of glucose (FPG and/or the OGTT) as the "gold standard" for the diagnosis of diabetes for many years, glucose testing suffers from several deficiencies. The requirement that the subject be fasting at the time the blood is drawn is a considerable inconvenience. While our ability to measure glucose has improved, inherent biological variability can produce very large differences within and among individuals. In conjunction with lack of sample stability, which is difficult to overcome in clinical practice, these factors results in lack of reproducibility of glucose testing.
A1C, which reflects chronic blood glucose values, is routinely used in monitoring glycemic control and guiding therapy. The significant reduction in microvascular complications with lower A1C and the absence of sample lability, combined with several other advantages (Table 3), have led to the recommendation by some organizations that A1C be used for screening and diagnosis of diabetes.
Accumulating evidence suggests that racial differences in A1C values may be present, and the possible clinical significance of this needs to be determined. Importantly, A1C cannot be measured in certain conditions. Despite these caveats, A1C can be measured accurately in the vast majority of people. A comprehension of the factors that influence A1C values and the conditions where it should not be used will produce accurate and clinically meaningful results.
The convenience of sampling at any time without regard to food ingestion makes it likely that measurement of A1C will result in the detection of many of the millions of people with diabetes who are currently undiagnosed.
Surgery and Low Back Pain -- Is the Choice Clear?
From Medscape Family Medicine > Best Evidence Review
Charles P. Vega, MD
Background
Low back pain is a very common condition, accounting for 2.3% of physician visits in the United States.
The total cost of low back pain exceeds $100 billion per year in the United States alone.
Two-thirds of these costs are related to lost wages and decreased productivity at work.
A small minority of patients with severe back pain account for a significant majority of the total socioeconomic cost of back pain.
Thus, it is not surprising that surgical treatment for low back pain has grown more widespread over the past 20 years.
The analysis of long-term data discussed in this review suggests that surgery is not superior to a short, intensive cognitive and exercise intervention among patients with common low back pain.
This research suggests that surgical treatment for chronic low back pain may be overused.
In an analysis of 2 national surveys performed in the United States in 2002, 26.4% of respondents reported a history of back pain lasting at least 1 day during the previous 3 months.
The prevalence of back pain was inversely related to educational attainment and income, and the rate of back pain appeared stable compared with estimates from the previous decade.
The practice dictum states that low back pain nearly always resolves spontaneously. This may be true, but important caveats are needed.
One study found that although the majority of patients discontinue seeking medical care for their low back pain, nearly 80% of these patients continued to experience some pain or disability at 1 year following their initial clinic visit for low back pain.
In a more recent study of 973 primary care patients with less than 2 weeks of low back pain, the rates of returning to work were approximately 50% at 14 days and 83% at 3 months.
However, these statistics belied the median recovery times for disability (31 days) and pain (58 days). Only 72% of participants reported complete recovery at 12 months.
The fact that many patients have lingering symptoms, in combination with the introduction and promotion of new surgical techniques and equipment, has led to an explosive increase in the use of surgery for low back pain. The estimated number of lumbar fusion procedures increased by an estimated 134% between 1993 and 2003; other estimates have suggested a more than 200% increase in the number of these procedures during a similar time frame.
But does surgery afford better outcomes to patients with chronic low back pain? Several studies have examined this issue.
A previous large trial of surgery for lumbar spondylolisthesis and spinal stenosis demonstrated that surgery did not improve pain or disability compared with usual care on intent-to-treat analysis.
However, significant crossover between the surgery and usual care groups occurred in this research, and as-treated analyses found that surgery improved pain, function, and disability at 2 years compared with usual care.
This research was important and provocative, but not necessarily definitive. Moreover, it did not compare surgery with an active intervention.
Previously, the authors of the current study reported on outcomes at 1 and 2 years in a comparison of lumbar fusion with a program of cognitive intervention and prescribed exercises among patients with chronic low back pain.
They found that outcomes were similar in the surgical and nonsurgical groups. However, given the chronic nature of low back pain among many patients, it remained unclear if their results would continue to remain the same in the very long term. The current study addresses this issue with a report from their patient cohort at 4 years.
Clinical Pearls
* More than one fourth of Americans have experienced significant back pain in the past 3 months, and the total cost of low back pain exceeds $100 billion per year in the United States alone;
* Surgical treatment of low back pain has become more prevalent;
* In the current study, an intensive, brief program of cognitive and exercise treatment produced similar outcomes as surgical treatment of chronic low back pain;
* The current study is in accord with previous systematic reviews of treatment for low back pain without significant anatomic changes (such as spinal stenosis) or symptoms (such as radiculopathy); and
* Further research could highlight how to use elements of the intensive back rehabilitation program in everyday practice
Charles P. Vega, MD
Background
Low back pain is a very common condition, accounting for 2.3% of physician visits in the United States.
The total cost of low back pain exceeds $100 billion per year in the United States alone.
Two-thirds of these costs are related to lost wages and decreased productivity at work.
A small minority of patients with severe back pain account for a significant majority of the total socioeconomic cost of back pain.
Thus, it is not surprising that surgical treatment for low back pain has grown more widespread over the past 20 years.
The analysis of long-term data discussed in this review suggests that surgery is not superior to a short, intensive cognitive and exercise intervention among patients with common low back pain.
This research suggests that surgical treatment for chronic low back pain may be overused.
In an analysis of 2 national surveys performed in the United States in 2002, 26.4% of respondents reported a history of back pain lasting at least 1 day during the previous 3 months.
The prevalence of back pain was inversely related to educational attainment and income, and the rate of back pain appeared stable compared with estimates from the previous decade.
The practice dictum states that low back pain nearly always resolves spontaneously. This may be true, but important caveats are needed.
One study found that although the majority of patients discontinue seeking medical care for their low back pain, nearly 80% of these patients continued to experience some pain or disability at 1 year following their initial clinic visit for low back pain.
In a more recent study of 973 primary care patients with less than 2 weeks of low back pain, the rates of returning to work were approximately 50% at 14 days and 83% at 3 months.
However, these statistics belied the median recovery times for disability (31 days) and pain (58 days). Only 72% of participants reported complete recovery at 12 months.
The fact that many patients have lingering symptoms, in combination with the introduction and promotion of new surgical techniques and equipment, has led to an explosive increase in the use of surgery for low back pain. The estimated number of lumbar fusion procedures increased by an estimated 134% between 1993 and 2003; other estimates have suggested a more than 200% increase in the number of these procedures during a similar time frame.
But does surgery afford better outcomes to patients with chronic low back pain? Several studies have examined this issue.
A previous large trial of surgery for lumbar spondylolisthesis and spinal stenosis demonstrated that surgery did not improve pain or disability compared with usual care on intent-to-treat analysis.
However, significant crossover between the surgery and usual care groups occurred in this research, and as-treated analyses found that surgery improved pain, function, and disability at 2 years compared with usual care.
This research was important and provocative, but not necessarily definitive. Moreover, it did not compare surgery with an active intervention.
Previously, the authors of the current study reported on outcomes at 1 and 2 years in a comparison of lumbar fusion with a program of cognitive intervention and prescribed exercises among patients with chronic low back pain.
They found that outcomes were similar in the surgical and nonsurgical groups. However, given the chronic nature of low back pain among many patients, it remained unclear if their results would continue to remain the same in the very long term. The current study addresses this issue with a report from their patient cohort at 4 years.
Clinical Pearls
* More than one fourth of Americans have experienced significant back pain in the past 3 months, and the total cost of low back pain exceeds $100 billion per year in the United States alone;
* Surgical treatment of low back pain has become more prevalent;
* In the current study, an intensive, brief program of cognitive and exercise treatment produced similar outcomes as surgical treatment of chronic low back pain;
* The current study is in accord with previous systematic reviews of treatment for low back pain without significant anatomic changes (such as spinal stenosis) or symptoms (such as radiculopathy); and
* Further research could highlight how to use elements of the intensive back rehabilitation program in everyday practice
Friday, March 4, 2011
Simple Prediction Rule for Walking After Spinal Cord Injury
From Medscape Medical News > Neurology
Megan Brooks
March 4, 2011 — Spinal cord injury experts have developed and validated a simple prediction rule to assess a patient's chances of walking independently 1 year after traumatic spinal cord injury.
The prediction rule combines the patient's age and the results of 4 neurologic tests and is more accurate than the American Spinal Injury Association/International Spinal Cord Society neurologic standard scale (AIS) grading system, the researchers say.
Joost J. van Middendorp, MD, from the Spine Unit, Radboud University Nijmegen Medical Centre, the Netherlands, and the European Multicenter Study on Human Spinal Cord Injury (EM-SCI) Study Group used ambulation outcome data from 492 patients enrolled in the EM-SCI to develop the prediction rule.
Their report appears in the March 4 online issue of The Lancet.
After logistic regression analysis, the final model included age (dichotomized at 65 years) and motor scores of the quadriceps femoris (L3) and gastrocsoleus (S1) muscles and light touch sensation of dermatomes L3 and S1.
Table. Clinical Prediction Rule Variables and Minimum and Maximum Scores
Variable Range of Test Scores Minimum Score Maximum score
Age ≥65 years 0 – 1 −10 0
Motor score L3 0 – 5 0 10
Motor score S1 0 – 5 0 10
Light touch score L3 0 – 2 0 10
Light touch score S1 0 – 2 0 10
Total −10 40
According to the investigators, the combination of age younger than 65 years and these 4 neurologic predictors showed "excellent discrimination" in distinguishing independent walkers at 1 year after injury from nonwalkers. The area under the receiver operating characteristics curve (AUC) was 0.956 (95% confidence interval [CI], 0.936 – 0.976; P < .0001).
A temporal validation study in a second group of 99 patients from Europe confirmed "excellent discriminating ability" of the prediction rule (AUC, 0.967; 95% CI, 0.939 – 0.995; P < .0001), the researchers report.
Patients with a score of −10 have a 0% chance of walking independently 1 year after injury, those with a score of 10 have about a 35% chance, those posting a score of 15 have about a 67% chance, and those with a score of 20 have about a 97% chance, the researchers say.
A post hoc analysis showed that the timing of examination (<24 hours, <72 hours, or <15 days after injury) had no significant effect on the accuracy of the prediction rule, they note.
Accuracy Tops AIS
Dr. van Middendorp told Medscape Medical News that the accuracy of the prediction rule was "significantly higher" (change in AUC, 0.058; 95% CI, 0.030 – 0.086; P < .0001) than was the accuracy of the AIS grading system (AUC, 0.898; 95% CI, 0.867 – 0.928; P < .0001).
"The prediction rule had a clear additional clinical value for the prediction of an individual's ability to walk independently in each of the AIS grades," he said. What's interesting, he added, was that the prediction rule had additional clinical value in particularly AIS grade B and C patients.
In AIS grade B, sensory but not motor function is preserved below the neurologic level and includes the sacral segments S4-S5. In AIS grade C, motor function is preserved below the neurologic level, and more than half of key muscles below the neurologic level have a muscle grade of less than 3.
"Particularly for these grades of severity, physicians experience difficulties in prognosticating," Dr. van Middendorp said.
Clinicians could use this rule to "counsel patients with traumatic spinal cord injury and their families during the initial phase after injury," the researchers write, and to set rehabilitation goals. It might also be helpful in stratifying patients in interventional trials.
The question remains, Dr. van Middendorp noted, "whether this rule is applicable in other settings/countries. To demonstrate this, external validation studies are required." He said his team is planning to conduct an external validation study in Australia. In practice, however, "physicians from all over the world may and probably will use the prediction rule without external validation," he speculated.
Accurate Prediction Possible
The authors of a linked Comment in The Lancet say this research suggests that light touch sensory testing is of similar prognostic value to pinprick sensory testing, "which is generally thought to be the most reliable prognostic indicator of neurological recovery.
"Indeed, these 2 modalities could be of similar prognostic value, in view of the fact that they are both transmitted in the spinothalamic tracts," note Professor Wagih Shafik El Masri and Dr. Naveen Kumar of Keele University and the Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestry, United Kingdom.
Dr. van Middendorp and colleagues report that although the addition of pinprick sensory result at L5 to their prediction rule resulted in a slightly higher AUC in the derivation group, its inclusion resulted in a marginally lower AUC in the validation group. Because they wanted the prediction rule to be as simple as possible, they included only the light touch sensory scores in the model, they explain.
Professor El Masri and Dr. Kumar say the researchers "should be congratulated for providing further strong evidence for the emerging view that accurate prediction of an individual's clinical ability to walk independently after traumatic spinal cord injury is possible."
They say further studies are needed to "assess the power of the various prognostic indicators and assess their value when applied at different times after injury."
Megan Brooks
March 4, 2011 — Spinal cord injury experts have developed and validated a simple prediction rule to assess a patient's chances of walking independently 1 year after traumatic spinal cord injury.
The prediction rule combines the patient's age and the results of 4 neurologic tests and is more accurate than the American Spinal Injury Association/International Spinal Cord Society neurologic standard scale (AIS) grading system, the researchers say.
Joost J. van Middendorp, MD, from the Spine Unit, Radboud University Nijmegen Medical Centre, the Netherlands, and the European Multicenter Study on Human Spinal Cord Injury (EM-SCI) Study Group used ambulation outcome data from 492 patients enrolled in the EM-SCI to develop the prediction rule.
Their report appears in the March 4 online issue of The Lancet.
After logistic regression analysis, the final model included age (dichotomized at 65 years) and motor scores of the quadriceps femoris (L3) and gastrocsoleus (S1) muscles and light touch sensation of dermatomes L3 and S1.
Table. Clinical Prediction Rule Variables and Minimum and Maximum Scores
Variable Range of Test Scores Minimum Score Maximum score
Age ≥65 years 0 – 1 −10 0
Motor score L3 0 – 5 0 10
Motor score S1 0 – 5 0 10
Light touch score L3 0 – 2 0 10
Light touch score S1 0 – 2 0 10
Total −10 40
According to the investigators, the combination of age younger than 65 years and these 4 neurologic predictors showed "excellent discrimination" in distinguishing independent walkers at 1 year after injury from nonwalkers. The area under the receiver operating characteristics curve (AUC) was 0.956 (95% confidence interval [CI], 0.936 – 0.976; P < .0001).
A temporal validation study in a second group of 99 patients from Europe confirmed "excellent discriminating ability" of the prediction rule (AUC, 0.967; 95% CI, 0.939 – 0.995; P < .0001), the researchers report.
Patients with a score of −10 have a 0% chance of walking independently 1 year after injury, those with a score of 10 have about a 35% chance, those posting a score of 15 have about a 67% chance, and those with a score of 20 have about a 97% chance, the researchers say.
A post hoc analysis showed that the timing of examination (<24 hours, <72 hours, or <15 days after injury) had no significant effect on the accuracy of the prediction rule, they note.
Accuracy Tops AIS
Dr. van Middendorp told Medscape Medical News that the accuracy of the prediction rule was "significantly higher" (change in AUC, 0.058; 95% CI, 0.030 – 0.086; P < .0001) than was the accuracy of the AIS grading system (AUC, 0.898; 95% CI, 0.867 – 0.928; P < .0001).
"The prediction rule had a clear additional clinical value for the prediction of an individual's ability to walk independently in each of the AIS grades," he said. What's interesting, he added, was that the prediction rule had additional clinical value in particularly AIS grade B and C patients.
In AIS grade B, sensory but not motor function is preserved below the neurologic level and includes the sacral segments S4-S5. In AIS grade C, motor function is preserved below the neurologic level, and more than half of key muscles below the neurologic level have a muscle grade of less than 3.
"Particularly for these grades of severity, physicians experience difficulties in prognosticating," Dr. van Middendorp said.
Clinicians could use this rule to "counsel patients with traumatic spinal cord injury and their families during the initial phase after injury," the researchers write, and to set rehabilitation goals. It might also be helpful in stratifying patients in interventional trials.
The question remains, Dr. van Middendorp noted, "whether this rule is applicable in other settings/countries. To demonstrate this, external validation studies are required." He said his team is planning to conduct an external validation study in Australia. In practice, however, "physicians from all over the world may and probably will use the prediction rule without external validation," he speculated.
Accurate Prediction Possible
The authors of a linked Comment in The Lancet say this research suggests that light touch sensory testing is of similar prognostic value to pinprick sensory testing, "which is generally thought to be the most reliable prognostic indicator of neurological recovery.
"Indeed, these 2 modalities could be of similar prognostic value, in view of the fact that they are both transmitted in the spinothalamic tracts," note Professor Wagih Shafik El Masri and Dr. Naveen Kumar of Keele University and the Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestry, United Kingdom.
Dr. van Middendorp and colleagues report that although the addition of pinprick sensory result at L5 to their prediction rule resulted in a slightly higher AUC in the derivation group, its inclusion resulted in a marginally lower AUC in the validation group. Because they wanted the prediction rule to be as simple as possible, they included only the light touch sensory scores in the model, they explain.
Professor El Masri and Dr. Kumar say the researchers "should be congratulated for providing further strong evidence for the emerging view that accurate prediction of an individual's clinical ability to walk independently after traumatic spinal cord injury is possible."
They say further studies are needed to "assess the power of the various prognostic indicators and assess their value when applied at different times after injury."
Thursday, March 3, 2011
Irritable Bowel Syndrome The Possible Benefits of Oral Antibiotic Therapy
From AccessMedicine from McGraw-Hill
Kurt J. Isselbacher
Irritable bowel syndrome (IBS) is one of the most common conditions in clinical practice, yet the number of effective treatments is limited. Perhaps this is not surprising because we lack a complete understanding of the underlying pathogenesis of this disorder and undoubtedly the disease is heterogeneous. Because gut flora may play an important role in the pathophysiology of IBS, Pimentel and colleagues (2011) have evaluated the role of rifaximin, a minimally absorbed antibiotic, as a potential treatment of IBS patients without constipation.
They carried out two identically designed, large, double-blind, placebo-controlled trials. A total of 1260 patients were randomly assigned to receive rifaximin at a dose of 550 mg three times daily or placebo for 2 weeks. There was then a follow-up period of 10 weeks after treatment. The primary endpoint was the proportion of patients who reported adequate relief of symptoms assessed weekly during the first 4 weeks after treatment. The second endpoint was the proportion of patients reporting adequate relief of bloating during the same period.
In the rifaximin groups, compared with the placebo groups, there was a significantly higher proportion of patients reporting (1) adequate relief of IBS symptoms in the two trials combined—41% vs 32% (p < .001)—and (2) relief of bloating—40% vs 30%— (p < .001) for at least the first 4 weeks.
In an accompanying editorial, Dr. Jan Tack (2011) comments positively on these data. He notes that (1) the sustained benefit over at least 10 weeks after the short pretreatment course was a positive sign; (2) the beneficial effects of rifaximin, including its effects on bloating, were impressive; and (3) the similarity of the results in the two studies confirms the reproducibility of the therapeutic effect of rifaximin. Commenting on the possible mode of action of rifaximin, Dr. Tack notes that "the most likely mode of action of rifaximin is a reduction in overall bacterial load, especially in the large bowel." He suggests that this obviously would lead to a decrease in bacterial fermentation and therefore less bloating.
It should be noted that there may be a subpopulation of IBS patients who have a better result with oral nonsystemic antibiotics than others. And finally, Dr. Tack noted that "it seems prudent to restrict the use of nonabsorbable antibiotics to patients in whom small-intestine bacterial over-growth has been confirmed, or to single-treatment cycles in patients who have IBS without constipation and who have not had a response to currently available symptom-directed therapies."
Kurt J. Isselbacher
Irritable bowel syndrome (IBS) is one of the most common conditions in clinical practice, yet the number of effective treatments is limited. Perhaps this is not surprising because we lack a complete understanding of the underlying pathogenesis of this disorder and undoubtedly the disease is heterogeneous. Because gut flora may play an important role in the pathophysiology of IBS, Pimentel and colleagues (2011) have evaluated the role of rifaximin, a minimally absorbed antibiotic, as a potential treatment of IBS patients without constipation.
They carried out two identically designed, large, double-blind, placebo-controlled trials. A total of 1260 patients were randomly assigned to receive rifaximin at a dose of 550 mg three times daily or placebo for 2 weeks. There was then a follow-up period of 10 weeks after treatment. The primary endpoint was the proportion of patients who reported adequate relief of symptoms assessed weekly during the first 4 weeks after treatment. The second endpoint was the proportion of patients reporting adequate relief of bloating during the same period.
In the rifaximin groups, compared with the placebo groups, there was a significantly higher proportion of patients reporting (1) adequate relief of IBS symptoms in the two trials combined—41% vs 32% (p < .001)—and (2) relief of bloating—40% vs 30%— (p < .001) for at least the first 4 weeks.
In an accompanying editorial, Dr. Jan Tack (2011) comments positively on these data. He notes that (1) the sustained benefit over at least 10 weeks after the short pretreatment course was a positive sign; (2) the beneficial effects of rifaximin, including its effects on bloating, were impressive; and (3) the similarity of the results in the two studies confirms the reproducibility of the therapeutic effect of rifaximin. Commenting on the possible mode of action of rifaximin, Dr. Tack notes that "the most likely mode of action of rifaximin is a reduction in overall bacterial load, especially in the large bowel." He suggests that this obviously would lead to a decrease in bacterial fermentation and therefore less bloating.
It should be noted that there may be a subpopulation of IBS patients who have a better result with oral nonsystemic antibiotics than others. And finally, Dr. Tack noted that "it seems prudent to restrict the use of nonabsorbable antibiotics to patients in whom small-intestine bacterial over-growth has been confirmed, or to single-treatment cycles in patients who have IBS without constipation and who have not had a response to currently available symptom-directed therapies."
Spirituality an Important Component of Patient Care
From Medscape Medical News
An Expert Interview With Christina M. Puchalski, MD
Jim Kling
March 2, 2011 — Editor's note: Until recent years, spirituality has been an oft-overlooked element of patient care. Numerous studies have suggested that having a spiritual community is helpful to people coping with illness and recovering from surgery. A discussion of improving spiritual care was featured at the American Academy of Hospice and Palliative Medicine/Hospice and Palliative Nurses Association Annual Assembly, held February 16 to 19 in Vancouver, British Columbia.
To find out more about spirituality and healthcare, Medscape Medical News interviewed Christina M. Puchalski, MD, executive director of The George Washington Institute for Spirituality and Health in Washington, DC, and professor of medicine and health sciences at The George Washington University School of Medicine. Dr. Puchalski helped develop the Faith and Belief, Importance, Community, and Address in Care (FICA) tool to help healthcare professionals address spiritual issues with their patients.
Spiritual distress is also an important factor in healthcare, and can be monitored as part of an overall screening plan. It is designed to be taken as part of the regular history during an annual exam or at an initial visit with a new patient. It consists of a series of questions addressing faith and belief, importance of that belief in the patient's life, the presence or absence of a spiritual community, and how spirituality should be addressed in care by the physician.
Medscape: How do you define spirituality?
Dr. Puchalski: Spirituality [refers to the way] people understand meaning and purpose in their lives. It can be affected by illness or loss, and it can be experienced in many ways — not just religion, but nature, arts, humanities, and rational thinking. Some say it is God, some say it is family, and some find it in nature. It's a very personal thing for people.
It's also important for physicians. Spirituality is about relationships. We talk about providing compassionate care. If you go into any hospital, it says its mission is to provide compassionate care.
Compassion means you're present with another human being, and unless a physician knows what gives his life meaning, the source of the call to serve others, it is very hard to be compassionate. Our profession is really a spiritual profession.
Medscape: How does spirituality come into play in common medical practice?
Dr. Puchalski: It's so important in palliative care because you're dealing with the possibility of dying. It's staring you in the face.
But aging is another aspect. I have a patient who is a bicyclist. Her community comes out of her biking group; she raises money for charities, she bikes internationally. She's healthy right now, but one thing we talked about was, if there [comes] a time when [she's] not able to do this, what is going to give [her] meaning then. She kind of shrugged it off, but the next year she came back and said that she had given thought to it. It would have been really hard for her to become inactive, but now she has other resources.
I had another who patient who had a mild stroke, which caused her to slow down. She later broke her elbow. The question the family had to deal with was whether or not to let the elbow heal as it was or to have surgery done. She probably would not have been able to straighten it without surgery. A key question was: What gives meaning to the patient? She is religious, but what was really important to her was her sense of dignity and independence. So we needed to fix her elbow and do the surgery. These questions can affect healthcare decision making.
The issues aren't just for end-of-life care. It's about conversations, about recognizing that conversations are important in clinical care and not just end-of-life care. Every single visit I have with a patient includes a conversation about spirituality, about what's important to them.
Every time we come to a crossroads that requires a decision, I want to know: 'Where are you today, what's important to you, what gives your life meaning and value, and how does this affect your decisions?'
Medscape: Tell me about the FICA tool.
Dr. Puchalski: I recommend that for every new patient, part of the social history should be a spiritual history. It should be used in annual exams as part of risk assessment, like anything else. . . We did a validation study comparing it to the City of Hope Quality of Life tool, which is more of a research-based tool, but we identified the same types of spiritual issues, so we know that FICA works.
If people aren't exercising, that's a problem. If people don't have a sense of meaning and purpose, that's another problem. People should also think about a spiritual history when there's a change in clinical status. When you're breaking bad news, I think it's important to ask about support systems and what might work for people. Spirituality is one of those things.
It gives people the tools to talk about and diagnose spiritual distress and to integrate it into a treatment plan. What we've done at The George Washington Institute for Spirituality and Health is develop tools and practical ways to integrate that into healthcare.
Medscape: What do you recommend that clinicians do if they see a spiritual problem developing in a patient?
Dr. Puchalski: It depends on what the issue is. If it's spiritual distress, ideally a board-certified chaplain might be the best referral, but in reality, there aren't that many available in an outpatient setting.
Let's say the issue is meaninglessness. There are a variety of options. Maybe it's talking to a pastoral counselor, or there are some therapists that are really good at dealing with these types of spiritual and emotional issues together. Art therapy might work for some.
If they want to deepen their relationship with God, however they understand that, then a spiritual director might be ideal.
Medscape: How do you distinguish between spiritual suffering and other issues, such as depression or social isolation?
Dr. Puchalski: It overlaps. Let's take depression. There's something called demoralization, which is a lack of meaning and purpose in life. Some would say that's psychological, but if you're talking about a sense of ultimate meaning, an inner sense of coherence of who you are — regardless of what's happening around you — you can be depressed and demoralized, you can be depressed and have no hope, you can be depressed and isolated from God.
What is important to do is to identify depression, meaning typically the patient has physical symptoms, like a change in appetite, feelings of worthlessness, inability to sleep, change of weight, or thoughts of suicide.
Someone could be clinically depressed but not necessarily have a really active spiritual issue, and once you get the depression stabilized, they're fine.
People can have spiritual issues, but not be clinically depressed. You have to dig deeper. This is a relatively new field, and we're just beginning to identify these different arenas. It's just like social and emotional issues — they overlap with physical pain. Many people tell me, 'my back really hurts, but stress really exacerbates it.' Maybe there's something physical there, but an emotional thing can exacerbate it.
Medscape: Is spirituality often overlooked in healthcare?
Dr. Puchalski: In 1992, I started a course at The George Washington School of Medicine on spirituality and health. It was the first such course then, but today more than 75% of medical schools in the United States teach content in spirituality and health. Some Canadian schools are doing it as well, and there's a growing interest in Europe.
I would say interest has certainly increased, as evidenced by the number of people asking me to use the FICA tool. It's now in medical textbooks, and it's been integrated into many electronic records in the hospital setting.
Religion has been on [healthcare assessment] forms, but that is not a spiritual history. It could be a part of it, but it misses the aspect of meaning, purpose, and connection. Increasingly, hospitals have deleted the question [of religion], or still have it but in addition ask something about spirituality.
We're really calling for a system change. We need something far more holistic than what we have right now, and that's what I think has been important about this work.
Dr. Puchalski has disclosed no financial conflicts of interest.
An Expert Interview With Christina M. Puchalski, MD
Jim Kling
March 2, 2011 — Editor's note: Until recent years, spirituality has been an oft-overlooked element of patient care. Numerous studies have suggested that having a spiritual community is helpful to people coping with illness and recovering from surgery. A discussion of improving spiritual care was featured at the American Academy of Hospice and Palliative Medicine/Hospice and Palliative Nurses Association Annual Assembly, held February 16 to 19 in Vancouver, British Columbia.
To find out more about spirituality and healthcare, Medscape Medical News interviewed Christina M. Puchalski, MD, executive director of The George Washington Institute for Spirituality and Health in Washington, DC, and professor of medicine and health sciences at The George Washington University School of Medicine. Dr. Puchalski helped develop the Faith and Belief, Importance, Community, and Address in Care (FICA) tool to help healthcare professionals address spiritual issues with their patients.
Spiritual distress is also an important factor in healthcare, and can be monitored as part of an overall screening plan. It is designed to be taken as part of the regular history during an annual exam or at an initial visit with a new patient. It consists of a series of questions addressing faith and belief, importance of that belief in the patient's life, the presence or absence of a spiritual community, and how spirituality should be addressed in care by the physician.
Medscape: How do you define spirituality?
Dr. Puchalski: Spirituality [refers to the way] people understand meaning and purpose in their lives. It can be affected by illness or loss, and it can be experienced in many ways — not just religion, but nature, arts, humanities, and rational thinking. Some say it is God, some say it is family, and some find it in nature. It's a very personal thing for people.
It's also important for physicians. Spirituality is about relationships. We talk about providing compassionate care. If you go into any hospital, it says its mission is to provide compassionate care.
Compassion means you're present with another human being, and unless a physician knows what gives his life meaning, the source of the call to serve others, it is very hard to be compassionate. Our profession is really a spiritual profession.
Medscape: How does spirituality come into play in common medical practice?
Dr. Puchalski: It's so important in palliative care because you're dealing with the possibility of dying. It's staring you in the face.
But aging is another aspect. I have a patient who is a bicyclist. Her community comes out of her biking group; she raises money for charities, she bikes internationally. She's healthy right now, but one thing we talked about was, if there [comes] a time when [she's] not able to do this, what is going to give [her] meaning then. She kind of shrugged it off, but the next year she came back and said that she had given thought to it. It would have been really hard for her to become inactive, but now she has other resources.
I had another who patient who had a mild stroke, which caused her to slow down. She later broke her elbow. The question the family had to deal with was whether or not to let the elbow heal as it was or to have surgery done. She probably would not have been able to straighten it without surgery. A key question was: What gives meaning to the patient? She is religious, but what was really important to her was her sense of dignity and independence. So we needed to fix her elbow and do the surgery. These questions can affect healthcare decision making.
The issues aren't just for end-of-life care. It's about conversations, about recognizing that conversations are important in clinical care and not just end-of-life care. Every single visit I have with a patient includes a conversation about spirituality, about what's important to them.
Every time we come to a crossroads that requires a decision, I want to know: 'Where are you today, what's important to you, what gives your life meaning and value, and how does this affect your decisions?'
Medscape: Tell me about the FICA tool.
Dr. Puchalski: I recommend that for every new patient, part of the social history should be a spiritual history. It should be used in annual exams as part of risk assessment, like anything else. . . We did a validation study comparing it to the City of Hope Quality of Life tool, which is more of a research-based tool, but we identified the same types of spiritual issues, so we know that FICA works.
If people aren't exercising, that's a problem. If people don't have a sense of meaning and purpose, that's another problem. People should also think about a spiritual history when there's a change in clinical status. When you're breaking bad news, I think it's important to ask about support systems and what might work for people. Spirituality is one of those things.
It gives people the tools to talk about and diagnose spiritual distress and to integrate it into a treatment plan. What we've done at The George Washington Institute for Spirituality and Health is develop tools and practical ways to integrate that into healthcare.
Medscape: What do you recommend that clinicians do if they see a spiritual problem developing in a patient?
Dr. Puchalski: It depends on what the issue is. If it's spiritual distress, ideally a board-certified chaplain might be the best referral, but in reality, there aren't that many available in an outpatient setting.
Let's say the issue is meaninglessness. There are a variety of options. Maybe it's talking to a pastoral counselor, or there are some therapists that are really good at dealing with these types of spiritual and emotional issues together. Art therapy might work for some.
If they want to deepen their relationship with God, however they understand that, then a spiritual director might be ideal.
Medscape: How do you distinguish between spiritual suffering and other issues, such as depression or social isolation?
Dr. Puchalski: It overlaps. Let's take depression. There's something called demoralization, which is a lack of meaning and purpose in life. Some would say that's psychological, but if you're talking about a sense of ultimate meaning, an inner sense of coherence of who you are — regardless of what's happening around you — you can be depressed and demoralized, you can be depressed and have no hope, you can be depressed and isolated from God.
What is important to do is to identify depression, meaning typically the patient has physical symptoms, like a change in appetite, feelings of worthlessness, inability to sleep, change of weight, or thoughts of suicide.
Someone could be clinically depressed but not necessarily have a really active spiritual issue, and once you get the depression stabilized, they're fine.
People can have spiritual issues, but not be clinically depressed. You have to dig deeper. This is a relatively new field, and we're just beginning to identify these different arenas. It's just like social and emotional issues — they overlap with physical pain. Many people tell me, 'my back really hurts, but stress really exacerbates it.' Maybe there's something physical there, but an emotional thing can exacerbate it.
Medscape: Is spirituality often overlooked in healthcare?
Dr. Puchalski: In 1992, I started a course at The George Washington School of Medicine on spirituality and health. It was the first such course then, but today more than 75% of medical schools in the United States teach content in spirituality and health. Some Canadian schools are doing it as well, and there's a growing interest in Europe.
I would say interest has certainly increased, as evidenced by the number of people asking me to use the FICA tool. It's now in medical textbooks, and it's been integrated into many electronic records in the hospital setting.
Religion has been on [healthcare assessment] forms, but that is not a spiritual history. It could be a part of it, but it misses the aspect of meaning, purpose, and connection. Increasingly, hospitals have deleted the question [of religion], or still have it but in addition ask something about spirituality.
We're really calling for a system change. We need something far more holistic than what we have right now, and that's what I think has been important about this work.
Dr. Puchalski has disclosed no financial conflicts of interest.
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