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Which patients with minor head injury do not need computed tomography?
BACKGROUND: Every year more than 2 million adults present to emergency departments in the United States with acute head trauma. Only 6% to 9% of those with apparently minor injury have an intracranial lesion by computed tomography (CT), and less than 1% will require neurosurgical intervention.1 This study develops and validates a clinical prediction guide for identifying patients with minor head injury who do not require a head CT.
POPULATION STUDIED: The study took place at a large inner city level 1 trauma center. All patients were aged at least 3 years and presented within 24 hours of a minor head injury. Minor head injury was defined as any loss of consciousness (witnessed, reported, or unknown) with a normal neurological examination and a Glasgow Coma Scale score of 15 with or without isolated deficits in short-term memory. Patients were excluded if they refused CT, had concurrent injuries precluding CT, or reported no loss of consciousness. The mean age was 36 years, and 65% were men.
STUDY DESIGN AND VALIDITY: This is a prospective validation of a clinical prediction guide. In phase 1 demographic data, symptoms, and physical findings were recorded for 520 consecutive patients with minor head injury. All of the study patients subsequently underwent CT of the head. Clinical criteria were correlated with CT findings, and a set of 7 findings was found that identified all patients with a positive CT. In phase 2, this set of 7 findings was prospectively validated in a group of 909 consecutive patients with minor head injury. The patients were analyzed in 2 groups: those who had at least one of the 7 findings and those who had none. Emergency medicine residents performed the clinical evaluations under faculty supervision. A second physician repeated the evaluation for 50 patients with 92% agreement (k=0.78). Staff neuroradiologists interpreted CT results, although it is a limitation of the study that the radiologists were apparently not blinded to the clinical condition of patients. An independent staff radiologist who was unaware of the original interpretations reviewed 50 randomly selected CT scans with 98% agreement (k=0.94). The rate of positive CT in each phase (6.9% and 6.3%, respectively) was consistent with previous studies.
OUTCOMES MEASURED: The primary outcome was the negative predictive value of the clinical prediction guide for the presence of significant head injury.
RESULTS: The following 7 findings identified all patients with a positive CT: (1) posttraumatic head pain, (2) posttraumatic emesis, (3) older than 60 years, (4) drug or alcohol intoxication, (5) deficits in short-term memory, (6) physical evidence of trauma above the clavicles, and (7) seizure. In phase 2 of the study the absence of all 7 of these findings had a negative predictive value for a positive CT of 100% (95% confidence interval, 99%-100%). Application of this clinical prediction guide to the 909 patients in phase 2 would have reduced the use of head CT by 22% without missing any abnormalities. This study did not have the power to evaluate the association seen in previous studies between coagulopathy and a positive head CT.
The authors of this study present compelling evidence that head CT is not needed for minor head injury in patients with none of the 7 findings listed. One unnecessary CT would be prevented for every 5 patients evaluated using this clinical decision rule. Based on previous studies, physicians should also obtain a CT on any patient with a coagulopathy. Given the potential for harm if the rule is inaccurate, it should be validated in another study before widespread use.
BACKGROUND: Every year more than 2 million adults present to emergency departments in the United States with acute head trauma. Only 6% to 9% of those with apparently minor injury have an intracranial lesion by computed tomography (CT), and less than 1% will require neurosurgical intervention.1 This study develops and validates a clinical prediction guide for identifying patients with minor head injury who do not require a head CT.
POPULATION STUDIED: The study took place at a large inner city level 1 trauma center. All patients were aged at least 3 years and presented within 24 hours of a minor head injury. Minor head injury was defined as any loss of consciousness (witnessed, reported, or unknown) with a normal neurological examination and a Glasgow Coma Scale score of 15 with or without isolated deficits in short-term memory. Patients were excluded if they refused CT, had concurrent injuries precluding CT, or reported no loss of consciousness. The mean age was 36 years, and 65% were men.
STUDY DESIGN AND VALIDITY: This is a prospective validation of a clinical prediction guide. In phase 1 demographic data, symptoms, and physical findings were recorded for 520 consecutive patients with minor head injury. All of the study patients subsequently underwent CT of the head. Clinical criteria were correlated with CT findings, and a set of 7 findings was found that identified all patients with a positive CT. In phase 2, this set of 7 findings was prospectively validated in a group of 909 consecutive patients with minor head injury. The patients were analyzed in 2 groups: those who had at least one of the 7 findings and those who had none. Emergency medicine residents performed the clinical evaluations under faculty supervision. A second physician repeated the evaluation for 50 patients with 92% agreement (k=0.78). Staff neuroradiologists interpreted CT results, although it is a limitation of the study that the radiologists were apparently not blinded to the clinical condition of patients. An independent staff radiologist who was unaware of the original interpretations reviewed 50 randomly selected CT scans with 98% agreement (k=0.94). The rate of positive CT in each phase (6.9% and 6.3%, respectively) was consistent with previous studies.
OUTCOMES MEASURED: The primary outcome was the negative predictive value of the clinical prediction guide for the presence of significant head injury.
RESULTS: The following 7 findings identified all patients with a positive CT: (1) posttraumatic head pain, (2) posttraumatic emesis, (3) older than 60 years, (4) drug or alcohol intoxication, (5) deficits in short-term memory, (6) physical evidence of trauma above the clavicles, and (7) seizure. In phase 2 of the study the absence of all 7 of these findings had a negative predictive value for a positive CT of 100% (95% confidence interval, 99%-100%). Application of this clinical prediction guide to the 909 patients in phase 2 would have reduced the use of head CT by 22% without missing any abnormalities. This study did not have the power to evaluate the association seen in previous studies between coagulopathy and a positive head CT.
The authors of this study present compelling evidence that head CT is not needed for minor head injury in patients with none of the 7 findings listed. One unnecessary CT would be prevented for every 5 patients evaluated using this clinical decision rule. Based on previous studies, physicians should also obtain a CT on any patient with a coagulopathy. Given the potential for harm if the rule is inaccurate, it should be validated in another study before widespread use.
BACKGROUND: Every year more than 2 million adults present to emergency departments in the United States with acute head trauma. Only 6% to 9% of those with apparently minor injury have an intracranial lesion by computed tomography (CT), and less than 1% will require neurosurgical intervention.1 This study develops and validates a clinical prediction guide for identifying patients with minor head injury who do not require a head CT.
POPULATION STUDIED: The study took place at a large inner city level 1 trauma center. All patients were aged at least 3 years and presented within 24 hours of a minor head injury. Minor head injury was defined as any loss of consciousness (witnessed, reported, or unknown) with a normal neurological examination and a Glasgow Coma Scale score of 15 with or without isolated deficits in short-term memory. Patients were excluded if they refused CT, had concurrent injuries precluding CT, or reported no loss of consciousness. The mean age was 36 years, and 65% were men.
STUDY DESIGN AND VALIDITY: This is a prospective validation of a clinical prediction guide. In phase 1 demographic data, symptoms, and physical findings were recorded for 520 consecutive patients with minor head injury. All of the study patients subsequently underwent CT of the head. Clinical criteria were correlated with CT findings, and a set of 7 findings was found that identified all patients with a positive CT. In phase 2, this set of 7 findings was prospectively validated in a group of 909 consecutive patients with minor head injury. The patients were analyzed in 2 groups: those who had at least one of the 7 findings and those who had none. Emergency medicine residents performed the clinical evaluations under faculty supervision. A second physician repeated the evaluation for 50 patients with 92% agreement (k=0.78). Staff neuroradiologists interpreted CT results, although it is a limitation of the study that the radiologists were apparently not blinded to the clinical condition of patients. An independent staff radiologist who was unaware of the original interpretations reviewed 50 randomly selected CT scans with 98% agreement (k=0.94). The rate of positive CT in each phase (6.9% and 6.3%, respectively) was consistent with previous studies.
OUTCOMES MEASURED: The primary outcome was the negative predictive value of the clinical prediction guide for the presence of significant head injury.
RESULTS: The following 7 findings identified all patients with a positive CT: (1) posttraumatic head pain, (2) posttraumatic emesis, (3) older than 60 years, (4) drug or alcohol intoxication, (5) deficits in short-term memory, (6) physical evidence of trauma above the clavicles, and (7) seizure. In phase 2 of the study the absence of all 7 of these findings had a negative predictive value for a positive CT of 100% (95% confidence interval, 99%-100%). Application of this clinical prediction guide to the 909 patients in phase 2 would have reduced the use of head CT by 22% without missing any abnormalities. This study did not have the power to evaluate the association seen in previous studies between coagulopathy and a positive head CT.
The authors of this study present compelling evidence that head CT is not needed for minor head injury in patients with none of the 7 findings listed. One unnecessary CT would be prevented for every 5 patients evaluated using this clinical decision rule. Based on previous studies, physicians should also obtain a CT on any patient with a coagulopathy. Given the potential for harm if the rule is inaccurate, it should be validated in another study before widespread use.
Neuroleptics for Behavioral Symptoms of Dementia
CLINICAL QUESTION: What is the efficacy and tolerability of risperidone for treating elderly demented patients with aggression and other behavioral symptoms?
BACKGROUND: Aggression and other behavioral symptoms of dementia are significant predictors of caregiver burden and may underlie the decision to institutionalize demented patients. Conventional neuroleptics are often used to manage disruptive behaviors. Adverse drug effects, however, such as movement disorders, extrapyramidal symptoms (EPS), anticholinergic effects, and drug-drug interactions limit their usefulness. Atypical antipsychotics such as risperidone may offer added benefit in elderly patients with dementia.
POPULATION STUDIED: The study recruited 371 nursing home patients from 51 centers in 8 countries. All had been given a diagnosis of primary degenerative dementia of the Alzheimer’s type, vascular dementia, or mixed dementia. Ages ranged from 56 to 97 years; 99% were white; and 56% were women. The median duration of institutionalization was 4 months. According to standardized measures, these patients had cognitive and functional deficits severe enough to affect basic daily activities. Mean Mini-Mental State Examination (MMSE) scores were 7.9 to 8.8.
STUDY DESIGN AND VALIDITY: Following a 1-week single-blind washout phase during which all psychotropic medications were discontinued, 344 patients were randomized to double-blind treatment with risperidone, haloperidol, or placebo. The study groups were comparable at baseline. The 12-week treatment period started with 0.25 mg (1 mg/mL oral solution) per day of risperidone or haloperidol. The dose was increased by 0.25 mg every 4 days up to a maximum of 2 mg twice daily. Efficacy was judged using several established behavioral assessment tools. Assessment of tolerability included evaluation for EPS, the level of sedation, Functional Assessment Staging, MMSE score, and the incidence of adverse drug effects. Outcomes were analyzed both by intention to treat (end point data) and observed case analysis that included only the 223 patients who continued treatment for 12 weeks (week 12 data). Of note, supplemental lorazepam was allowed in the first 4 weeks of the study, but concomitant use of antipsychotics, antidepressants, lithium, carbamazepine, and valproic acid was not otherwise permitted. This study was funded in part by Janssen Pharmaceuticals, maker of Risperdal (risperidone).
OUTCOMES MEASURED: The primary outcome was clinically significant improvement of disturbing behavior defined as a 30% or greater change on the Behavior Pathology in Alzheimer’s Disease Rating Scale (BEHAVE-AD) total score. Many secondary outcomes were reported regarding the efficacy of risperidone compared with placebo and its tolerability compared with both placebo and haloperidol.
RESULTS: The percentage of patients with clinical improvement (30% improvement in BEHAVE-AD total score) in the risperidone, haloperidol, and placebo groups was 54%, 63%, and 47% respectively by intention-to-treat analysis. This difference was not statistically significant (P = .25 with 80% power to detect a difference of 20%). The high placebo response may explain the poor effect overall of active treatment.1 Non-intention-to-treat analysis and secondary measures of behavior, particularly those assessing aggression, showed a statistically significant benefit of risperidone over placebo. This study was not intended to compare the efficacy of risperidone with that of haloperidol although a post hoc analysis was reported. In terms of tolerability, the severity of EPS was significantly greater with haloperidol than risperidone. There was no significant difference in the occurrence of serious adverse events. Dropout rates for the risperidone, haloperidol, and placebo groups were high (41%, 30%, and 35%, respectively). The most common reasons cited for discontinuation were adverse events (50.4%) and lack of efficacy (43.8%). The mean dose of medication was approximately 1 mg per day in both active groups.
If a pharmacological agent is deemed necessary in the management of behavior disturbances in patients with dementia, then risperidone offers comparable efficacy with haloperidol with less EPS. A cost-effectiveness analysis may be needed to justify the added expense of risperidone ($73.00 for 30 1-mg tablets vs $8.50 for haloperidol). Although secondary outcomes and the observed case analysis suggest a benefit compared with haloperidol and placebo, further study is needed to confirm the statistical validity and clinical significance of these results. Future trials should investigate whether the use of neuroleptics for behavior disturbances actually delays admission to extended-care facilities.
CLINICAL QUESTION: What is the efficacy and tolerability of risperidone for treating elderly demented patients with aggression and other behavioral symptoms?
BACKGROUND: Aggression and other behavioral symptoms of dementia are significant predictors of caregiver burden and may underlie the decision to institutionalize demented patients. Conventional neuroleptics are often used to manage disruptive behaviors. Adverse drug effects, however, such as movement disorders, extrapyramidal symptoms (EPS), anticholinergic effects, and drug-drug interactions limit their usefulness. Atypical antipsychotics such as risperidone may offer added benefit in elderly patients with dementia.
POPULATION STUDIED: The study recruited 371 nursing home patients from 51 centers in 8 countries. All had been given a diagnosis of primary degenerative dementia of the Alzheimer’s type, vascular dementia, or mixed dementia. Ages ranged from 56 to 97 years; 99% were white; and 56% were women. The median duration of institutionalization was 4 months. According to standardized measures, these patients had cognitive and functional deficits severe enough to affect basic daily activities. Mean Mini-Mental State Examination (MMSE) scores were 7.9 to 8.8.
STUDY DESIGN AND VALIDITY: Following a 1-week single-blind washout phase during which all psychotropic medications were discontinued, 344 patients were randomized to double-blind treatment with risperidone, haloperidol, or placebo. The study groups were comparable at baseline. The 12-week treatment period started with 0.25 mg (1 mg/mL oral solution) per day of risperidone or haloperidol. The dose was increased by 0.25 mg every 4 days up to a maximum of 2 mg twice daily. Efficacy was judged using several established behavioral assessment tools. Assessment of tolerability included evaluation for EPS, the level of sedation, Functional Assessment Staging, MMSE score, and the incidence of adverse drug effects. Outcomes were analyzed both by intention to treat (end point data) and observed case analysis that included only the 223 patients who continued treatment for 12 weeks (week 12 data). Of note, supplemental lorazepam was allowed in the first 4 weeks of the study, but concomitant use of antipsychotics, antidepressants, lithium, carbamazepine, and valproic acid was not otherwise permitted. This study was funded in part by Janssen Pharmaceuticals, maker of Risperdal (risperidone).
OUTCOMES MEASURED: The primary outcome was clinically significant improvement of disturbing behavior defined as a 30% or greater change on the Behavior Pathology in Alzheimer’s Disease Rating Scale (BEHAVE-AD) total score. Many secondary outcomes were reported regarding the efficacy of risperidone compared with placebo and its tolerability compared with both placebo and haloperidol.
RESULTS: The percentage of patients with clinical improvement (30% improvement in BEHAVE-AD total score) in the risperidone, haloperidol, and placebo groups was 54%, 63%, and 47% respectively by intention-to-treat analysis. This difference was not statistically significant (P = .25 with 80% power to detect a difference of 20%). The high placebo response may explain the poor effect overall of active treatment.1 Non-intention-to-treat analysis and secondary measures of behavior, particularly those assessing aggression, showed a statistically significant benefit of risperidone over placebo. This study was not intended to compare the efficacy of risperidone with that of haloperidol although a post hoc analysis was reported. In terms of tolerability, the severity of EPS was significantly greater with haloperidol than risperidone. There was no significant difference in the occurrence of serious adverse events. Dropout rates for the risperidone, haloperidol, and placebo groups were high (41%, 30%, and 35%, respectively). The most common reasons cited for discontinuation were adverse events (50.4%) and lack of efficacy (43.8%). The mean dose of medication was approximately 1 mg per day in both active groups.
If a pharmacological agent is deemed necessary in the management of behavior disturbances in patients with dementia, then risperidone offers comparable efficacy with haloperidol with less EPS. A cost-effectiveness analysis may be needed to justify the added expense of risperidone ($73.00 for 30 1-mg tablets vs $8.50 for haloperidol). Although secondary outcomes and the observed case analysis suggest a benefit compared with haloperidol and placebo, further study is needed to confirm the statistical validity and clinical significance of these results. Future trials should investigate whether the use of neuroleptics for behavior disturbances actually delays admission to extended-care facilities.
CLINICAL QUESTION: What is the efficacy and tolerability of risperidone for treating elderly demented patients with aggression and other behavioral symptoms?
BACKGROUND: Aggression and other behavioral symptoms of dementia are significant predictors of caregiver burden and may underlie the decision to institutionalize demented patients. Conventional neuroleptics are often used to manage disruptive behaviors. Adverse drug effects, however, such as movement disorders, extrapyramidal symptoms (EPS), anticholinergic effects, and drug-drug interactions limit their usefulness. Atypical antipsychotics such as risperidone may offer added benefit in elderly patients with dementia.
POPULATION STUDIED: The study recruited 371 nursing home patients from 51 centers in 8 countries. All had been given a diagnosis of primary degenerative dementia of the Alzheimer’s type, vascular dementia, or mixed dementia. Ages ranged from 56 to 97 years; 99% were white; and 56% were women. The median duration of institutionalization was 4 months. According to standardized measures, these patients had cognitive and functional deficits severe enough to affect basic daily activities. Mean Mini-Mental State Examination (MMSE) scores were 7.9 to 8.8.
STUDY DESIGN AND VALIDITY: Following a 1-week single-blind washout phase during which all psychotropic medications were discontinued, 344 patients were randomized to double-blind treatment with risperidone, haloperidol, or placebo. The study groups were comparable at baseline. The 12-week treatment period started with 0.25 mg (1 mg/mL oral solution) per day of risperidone or haloperidol. The dose was increased by 0.25 mg every 4 days up to a maximum of 2 mg twice daily. Efficacy was judged using several established behavioral assessment tools. Assessment of tolerability included evaluation for EPS, the level of sedation, Functional Assessment Staging, MMSE score, and the incidence of adverse drug effects. Outcomes were analyzed both by intention to treat (end point data) and observed case analysis that included only the 223 patients who continued treatment for 12 weeks (week 12 data). Of note, supplemental lorazepam was allowed in the first 4 weeks of the study, but concomitant use of antipsychotics, antidepressants, lithium, carbamazepine, and valproic acid was not otherwise permitted. This study was funded in part by Janssen Pharmaceuticals, maker of Risperdal (risperidone).
OUTCOMES MEASURED: The primary outcome was clinically significant improvement of disturbing behavior defined as a 30% or greater change on the Behavior Pathology in Alzheimer’s Disease Rating Scale (BEHAVE-AD) total score. Many secondary outcomes were reported regarding the efficacy of risperidone compared with placebo and its tolerability compared with both placebo and haloperidol.
RESULTS: The percentage of patients with clinical improvement (30% improvement in BEHAVE-AD total score) in the risperidone, haloperidol, and placebo groups was 54%, 63%, and 47% respectively by intention-to-treat analysis. This difference was not statistically significant (P = .25 with 80% power to detect a difference of 20%). The high placebo response may explain the poor effect overall of active treatment.1 Non-intention-to-treat analysis and secondary measures of behavior, particularly those assessing aggression, showed a statistically significant benefit of risperidone over placebo. This study was not intended to compare the efficacy of risperidone with that of haloperidol although a post hoc analysis was reported. In terms of tolerability, the severity of EPS was significantly greater with haloperidol than risperidone. There was no significant difference in the occurrence of serious adverse events. Dropout rates for the risperidone, haloperidol, and placebo groups were high (41%, 30%, and 35%, respectively). The most common reasons cited for discontinuation were adverse events (50.4%) and lack of efficacy (43.8%). The mean dose of medication was approximately 1 mg per day in both active groups.
If a pharmacological agent is deemed necessary in the management of behavior disturbances in patients with dementia, then risperidone offers comparable efficacy with haloperidol with less EPS. A cost-effectiveness analysis may be needed to justify the added expense of risperidone ($73.00 for 30 1-mg tablets vs $8.50 for haloperidol). Although secondary outcomes and the observed case analysis suggest a benefit compared with haloperidol and placebo, further study is needed to confirm the statistical validity and clinical significance of these results. Future trials should investigate whether the use of neuroleptics for behavior disturbances actually delays admission to extended-care facilities.