James Brillhart, MD, MPH & TM

BACKGROUND: The upper respiratory tract is usually colonized by nonpathogenic bacteria that provide a protective effect against the organisms that cause otitis media and pharyngotonsillitis. Alpha-streptococci isolated from normal pharyngeal flora inhibit the growth of Group A b-hemolytic streptococcus (GAS) in vitro and prevent recurrence of GAS pharyngitis. Similarly, healthy children have higher levels of inhibitory a-streptococci compared with children prone to otitis media. This investigation sought to determine whether recolonization of the nasopharynx with a nasal spray of a-streptococci prevents the recurrence of otitis media in children.

POPULATION STUDIED: Three ear, nose, and throat (ENT) physicians enrolled 132 children with recurrent otitis media aged between 6 months and 6 years at an outpatient specialty clinic in Sweden. Each child had at least 2 episodes of otitis media in the previous 6 months or 5 episodes in the last year. When such children presented with acute otitis media, they were enrolled in the study and began a 10-day course of antibiotics. Children were excluded from the study if they had penicillin allergy, pressure equalizing tubes, chronic otitis media, serious underlying disease, or major oral lesions.

STUDY DESIGN AND VALIDITY: After completing the 10-day course of penicillin V or amoxicillin clavulanic acid, the children were randomized to receive either a nasal spray made with 5 strains of a-streptococci or a placebo spray. Parents gave their children 3 puffs of spray in each nostril twice daily for 10 days. At day 60, a second course of spray was administered. Subjects were followed up for 3 months. Of 132 children enrolled, 108 (82%) were eligible for analysis of efficacy (using at least 50% of their sprays). The authors used concealed allocation; their randomization worked well; and the follow-up was satisfactory.

OUTCOMES MEASURED: Each subject had 5 scheduled visits to the ENT specialist during the course of the investigation. At each visit a detailed inspection of the tympanic membrane was performed using otomicroscopy. The clinical response to treatment was classified as cured, improved, secretory (serous) otitis media, or recurrent (acute otitis media). The main outcome measures were recurrence of otitis media and presence of a normal tympanic membrane at the last visit.

RESULTS: Children who received the a-streptococcal spray had a significant reduction in recurrence of otitis media compared with those receiving placebo. During the investigation, 42% of the subjects who received the a-streptococcal spray experienced no acute otitis media and had normal tympanic membranes at the last visit compared with 22% of the placebo group (adjusted relative risk [ARR]=20%; 95% confidence interval [CI], 2.8%-37%; number needed to treat [NNT]=5). There were fewer children in the treated group with secretory otitis media at the last visit (ARR=9%; 95% CI, 6.5%-28.5%; NNT=11). Side effects were roughly the same in both groups; the only patients who dropped out because of adverse effects were in the placebo group.

BACKGROUND: The upper respiratory tract is usually colonized by nonpathogenic bacteria that provide a protective effect against the organisms that cause otitis media and pharyngotonsillitis. Alpha-streptococci isolated from normal pharyngeal flora inhibit the growth of Group A b-hemolytic streptococcus (GAS) in vitro and prevent recurrence of GAS pharyngitis. Similarly, healthy children have higher levels of inhibitory a-streptococci compared with children prone to otitis media. This investigation sought to determine whether recolonization of the nasopharynx with a nasal spray of a-streptococci prevents the recurrence of otitis media in children.

POPULATION STUDIED: Three ear, nose, and throat (ENT) physicians enrolled 132 children with recurrent otitis media aged between 6 months and 6 years at an outpatient specialty clinic in Sweden. Each child had at least 2 episodes of otitis media in the previous 6 months or 5 episodes in the last year. When such children presented with acute otitis media, they were enrolled in the study and began a 10-day course of antibiotics. Children were excluded from the study if they had penicillin allergy, pressure equalizing tubes, chronic otitis media, serious underlying disease, or major oral lesions.

STUDY DESIGN AND VALIDITY: After completing the 10-day course of penicillin V or amoxicillin clavulanic acid, the children were randomized to receive either a nasal spray made with 5 strains of a-streptococci or a placebo spray. Parents gave their children 3 puffs of spray in each nostril twice daily for 10 days. At day 60, a second course of spray was administered. Subjects were followed up for 3 months. Of 132 children enrolled, 108 (82%) were eligible for analysis of efficacy (using at least 50% of their sprays). The authors used concealed allocation; their randomization worked well; and the follow-up was satisfactory.

OUTCOMES MEASURED: Each subject had 5 scheduled visits to the ENT specialist during the course of the investigation. At each visit a detailed inspection of the tympanic membrane was performed using otomicroscopy. The clinical response to treatment was classified as cured, improved, secretory (serous) otitis media, or recurrent (acute otitis media). The main outcome measures were recurrence of otitis media and presence of a normal tympanic membrane at the last visit.

RESULTS: Children who received the a-streptococcal spray had a significant reduction in recurrence of otitis media compared with those receiving placebo. During the investigation, 42% of the subjects who received the a-streptococcal spray experienced no acute otitis media and had normal tympanic membranes at the last visit compared with 22% of the placebo group (adjusted relative risk [ARR]=20%; 95% confidence interval [CI], 2.8%-37%; number needed to treat [NNT]=5). There were fewer children in the treated group with secretory otitis media at the last visit (ARR=9%; 95% CI, 6.5%-28.5%; NNT=11). Side effects were roughly the same in both groups; the only patients who dropped out because of adverse effects were in the placebo group.

BACKGROUND: The upper respiratory tract is usually colonized by nonpathogenic bacteria that provide a protective effect against the organisms that cause otitis media and pharyngotonsillitis. Alpha-streptococci isolated from normal pharyngeal flora inhibit the growth of Group A b-hemolytic streptococcus (GAS) in vitro and prevent recurrence of GAS pharyngitis. Similarly, healthy children have higher levels of inhibitory a-streptococci compared with children prone to otitis media. This investigation sought to determine whether recolonization of the nasopharynx with a nasal spray of a-streptococci prevents the recurrence of otitis media in children.

POPULATION STUDIED: Three ear, nose, and throat (ENT) physicians enrolled 132 children with recurrent otitis media aged between 6 months and 6 years at an outpatient specialty clinic in Sweden. Each child had at least 2 episodes of otitis media in the previous 6 months or 5 episodes in the last year. When such children presented with acute otitis media, they were enrolled in the study and began a 10-day course of antibiotics. Children were excluded from the study if they had penicillin allergy, pressure equalizing tubes, chronic otitis media, serious underlying disease, or major oral lesions.

STUDY DESIGN AND VALIDITY: After completing the 10-day course of penicillin V or amoxicillin clavulanic acid, the children were randomized to receive either a nasal spray made with 5 strains of a-streptococci or a placebo spray. Parents gave their children 3 puffs of spray in each nostril twice daily for 10 days. At day 60, a second course of spray was administered. Subjects were followed up for 3 months. Of 132 children enrolled, 108 (82%) were eligible for analysis of efficacy (using at least 50% of their sprays). The authors used concealed allocation; their randomization worked well; and the follow-up was satisfactory.

OUTCOMES MEASURED: Each subject had 5 scheduled visits to the ENT specialist during the course of the investigation. At each visit a detailed inspection of the tympanic membrane was performed using otomicroscopy. The clinical response to treatment was classified as cured, improved, secretory (serous) otitis media, or recurrent (acute otitis media). The main outcome measures were recurrence of otitis media and presence of a normal tympanic membrane at the last visit.

RESULTS: Children who received the a-streptococcal spray had a significant reduction in recurrence of otitis media compared with those receiving placebo. During the investigation, 42% of the subjects who received the a-streptococcal spray experienced no acute otitis media and had normal tympanic membranes at the last visit compared with 22% of the placebo group (adjusted relative risk [ARR]=20%; 95% confidence interval [CI], 2.8%-37%; number needed to treat [NNT]=5). There were fewer children in the treated group with secretory otitis media at the last visit (ARR=9%; 95% CI, 6.5%-28.5%; NNT=11). Side effects were roughly the same in both groups; the only patients who dropped out because of adverse effects were in the placebo group.

BACKGROUND: Fear of occult cervical spine injury in patients who have experienced blunt trauma compels clinicians to liberally order cervical spine radiographs. Consequently, a high percentage of normal radiographs are obtained at a high monetary cost. The National Emergency X-Radiography Utilization Study (NEXUS) was conducted to validate a simple clinical prediction guide used to identify blunt trauma patients at low risk for cervical spine injury.

POPULATION STUDIED: All blunt trauma patients who had cervical x-rays in 21 emergency departments across the country were enrolled in this investigation. The study sites were located in hospitals that varied in size, level of activity of the emergency department, level of care, and other factors. The patients ranged in age from 1 year to 101 years; the mean age was 37 years.

STUDY DESIGN AND VALIDITY: This was a prospective validation of a clinical prediction guide. This guide rules out the need for cervical radiography if 5 clinical criteria are fulfilled: (1) absence of tenderness at the posterior midline of the cervical spine, (2) absence of a focal neurologic deficit, (3) a normal level of alertness, (4) no evidence of intoxication, and (5) absence of clinically apparent pain that might distract the patient from the pain of a cervical spine injury. Clinicians treating blunt trauma patients prospectively completed a study data form that included assessment of the 5 clinical criteria and demographic information. Each patient received cervical x-rays at the discretion of the treating physician, who was instructed to use his usual criteria for obtaining radiographs. Designated radiologists at each study site formally interpreted all radiographs while being blinded to the clinical assessment of the treating physician. The statistical analysis included basic performance measures of the decision instrument (sensitivity, specificity, positive predictive value, and negative predictive value). Two limitations of the study are that the 5 clinical criteria are open to some individual interpretation, and that “blunt trauma” was not defined. The treating clinicians were also not blinded to the decision instrument being tested.

OUTCOME MEASURED: The primary outcomes were the sensitivity, specificity, positive predictive value, and negative predictive value of the clinical prediction guide for the detection of radiographically confirmed cervical spine injury.

RESULTS: of 34,069 patients who underwent cervical spine radiography, 818 (2.4%) had documented cervical spine injuries. Although the clinical prediction guide failed to identify 8 of these injuries, only 2 were classified as clinically significant. The negative predictive value of the 5 clinical criteria for patients who did not have clinically significant injuries was 99.9% (95% confidence interval, 99.8%-100%). In other words, blunt trauma patients who screen negative for all 5 clinical criteria have a 99.9% chance of not having a clinically significant injury. The decision instrument identified 4306 patients (12.6%) as having low probability of cervical spine injury. These patients could have been spared radiographic evaluation.

BACKGROUND: Fear of occult cervical spine injury in patients who have experienced blunt trauma compels clinicians to liberally order cervical spine radiographs. Consequently, a high percentage of normal radiographs are obtained at a high monetary cost. The National Emergency X-Radiography Utilization Study (NEXUS) was conducted to validate a simple clinical prediction guide used to identify blunt trauma patients at low risk for cervical spine injury.

POPULATION STUDIED: All blunt trauma patients who had cervical x-rays in 21 emergency departments across the country were enrolled in this investigation. The study sites were located in hospitals that varied in size, level of activity of the emergency department, level of care, and other factors. The patients ranged in age from 1 year to 101 years; the mean age was 37 years.

STUDY DESIGN AND VALIDITY: This was a prospective validation of a clinical prediction guide. This guide rules out the need for cervical radiography if 5 clinical criteria are fulfilled: (1) absence of tenderness at the posterior midline of the cervical spine, (2) absence of a focal neurologic deficit, (3) a normal level of alertness, (4) no evidence of intoxication, and (5) absence of clinically apparent pain that might distract the patient from the pain of a cervical spine injury. Clinicians treating blunt trauma patients prospectively completed a study data form that included assessment of the 5 clinical criteria and demographic information. Each patient received cervical x-rays at the discretion of the treating physician, who was instructed to use his usual criteria for obtaining radiographs. Designated radiologists at each study site formally interpreted all radiographs while being blinded to the clinical assessment of the treating physician. The statistical analysis included basic performance measures of the decision instrument (sensitivity, specificity, positive predictive value, and negative predictive value). Two limitations of the study are that the 5 clinical criteria are open to some individual interpretation, and that “blunt trauma” was not defined. The treating clinicians were also not blinded to the decision instrument being tested.

OUTCOME MEASURED: The primary outcomes were the sensitivity, specificity, positive predictive value, and negative predictive value of the clinical prediction guide for the detection of radiographically confirmed cervical spine injury.

RESULTS: of 34,069 patients who underwent cervical spine radiography, 818 (2.4%) had documented cervical spine injuries. Although the clinical prediction guide failed to identify 8 of these injuries, only 2 were classified as clinically significant. The negative predictive value of the 5 clinical criteria for patients who did not have clinically significant injuries was 99.9% (95% confidence interval, 99.8%-100%). In other words, blunt trauma patients who screen negative for all 5 clinical criteria have a 99.9% chance of not having a clinically significant injury. The decision instrument identified 4306 patients (12.6%) as having low probability of cervical spine injury. These patients could have been spared radiographic evaluation.

BACKGROUND: Fear of occult cervical spine injury in patients who have experienced blunt trauma compels clinicians to liberally order cervical spine radiographs. Consequently, a high percentage of normal radiographs are obtained at a high monetary cost. The National Emergency X-Radiography Utilization Study (NEXUS) was conducted to validate a simple clinical prediction guide used to identify blunt trauma patients at low risk for cervical spine injury.

POPULATION STUDIED: All blunt trauma patients who had cervical x-rays in 21 emergency departments across the country were enrolled in this investigation. The study sites were located in hospitals that varied in size, level of activity of the emergency department, level of care, and other factors. The patients ranged in age from 1 year to 101 years; the mean age was 37 years.

STUDY DESIGN AND VALIDITY: This was a prospective validation of a clinical prediction guide. This guide rules out the need for cervical radiography if 5 clinical criteria are fulfilled: (1) absence of tenderness at the posterior midline of the cervical spine, (2) absence of a focal neurologic deficit, (3) a normal level of alertness, (4) no evidence of intoxication, and (5) absence of clinically apparent pain that might distract the patient from the pain of a cervical spine injury. Clinicians treating blunt trauma patients prospectively completed a study data form that included assessment of the 5 clinical criteria and demographic information. Each patient received cervical x-rays at the discretion of the treating physician, who was instructed to use his usual criteria for obtaining radiographs. Designated radiologists at each study site formally interpreted all radiographs while being blinded to the clinical assessment of the treating physician. The statistical analysis included basic performance measures of the decision instrument (sensitivity, specificity, positive predictive value, and negative predictive value). Two limitations of the study are that the 5 clinical criteria are open to some individual interpretation, and that “blunt trauma” was not defined. The treating clinicians were also not blinded to the decision instrument being tested.

OUTCOME MEASURED: The primary outcomes were the sensitivity, specificity, positive predictive value, and negative predictive value of the clinical prediction guide for the detection of radiographically confirmed cervical spine injury.

RESULTS: of 34,069 patients who underwent cervical spine radiography, 818 (2.4%) had documented cervical spine injuries. Although the clinical prediction guide failed to identify 8 of these injuries, only 2 were classified as clinically significant. The negative predictive value of the 5 clinical criteria for patients who did not have clinically significant injuries was 99.9% (95% confidence interval, 99.8%-100%). In other words, blunt trauma patients who screen negative for all 5 clinical criteria have a 99.9% chance of not having a clinically significant injury. The decision instrument identified 4306 patients (12.6%) as having low probability of cervical spine injury. These patients could have been spared radiographic evaluation.