Appendix 6 DATA EXTRACTION FOR PAPERS DESCRIBING RULES FOR HEAD CT SELECTION: ADULTS

Transcription

1 Appendix 6 DATA EXTRACTION FOR PAPERS DESCRIBING RULES FOR HEAD CT SELECTION: ADULTS Names and level Rule description Participants Outcomes Specificity Sensitivity CT ordering rate Prevalence Derived using primary data Derived using prospect. data Validated using primary data Validated using prospect. data Multivariate modelling Follow-up Notes Head injury full guideline, appendix 6; second consultation 1

2 Stiell et al (2001) 1 Canadian CT Head Rule (5 and 7 variables) Level 2 Well constructed derivation of rule A five variable rule has been developed when the outcome is need for neurological intervention. Immediate CT for all with the following: GCS<15; Open or depressed skull fracture; Basal skull fracture signs; 2 or more vomit; Age more than 64 years. Non-CT eligible discharged. A seven variable rule has also been developed when clinically important brain injury is the intended outcome. The rule is as above plus: Amnesia before impact > 30min; Dangerous mechanism (motor vehicle ejection, pedestrian struck by motor vehicle, fall from > 3 ft or 5 stairs) N = 3121 GCS 13-15, with LOC/PTA and history of trauma, and no signs of penetrating trauma, or seizure Age >16 yrs Patients attending 10 Canadian emergency departments Clinically important brain injury (CIBI) for seven variable rule. Need for neurosurgical intervention for five variable rule. 49.6% (48-51%) for the 7 variable rule 68.7% (67-70%) for the 5 variable rule 98.4% (96-99%) for the 7 variable rule 100% (92-100%) for the 5 variable rule 54.3% for the 7 variable rule 32.2% for the five variable rule 8% had CIBI 1% needed neurosurgica l intervention Yes Yes Yes (in a subsample) Yes (in a subsample) Yes 67% had CT-scan 21% clinical follow-up by telephone at 14 days. 363 not followed up (12%) Assumption is that trivial injuries are discharged (n LOC, amnesia, disorientat all GCS<13 would receive immediate CT, even thoug rules not developed for thi group; clinical follow-up is as sensitive as CT (estima that up to 13% of CIBI cou have been missed). These rules are in the proc of being validated. The la sample size gives greater confidence in the prelimina validation carried out on th derivation sample eligible were enrolled (logistics) Note: this rule does not inc headache as a variable, w some UK clinicians may fin unacceptable. This was du the fact that their data collection only recorded presence or absence of headache and did not divid this category into mild moderate and severe headache, therefore significance was not found Head injury full guideline, appendix 6; second consultation 2

3 Duus et al (1994) 2 Duus et al (1993) 3 provides the derivation data Level 1 Well constructed derivation and validation of rule Admit the following for observation: Confusion or aggression Impaired consciousness Focal neurological signs Skull fracture suspected Alcohol intoxication History of convulsions Amnesia before impact > 15 mins LOC more than 15mins <3yrs old, with headaches and vomiting Nobody at home for observation CT-scan performed when a decline in consciousness or neurological signs is observed N=2204 attenders at A&E able to talk and walk even if unclear speech No information on GCS Adults and children Single Danish Hospital Death Need for neuro intervention 0% (all those that did not need observation received it) 98% 1% 0.2% needed neuro intervention Yes No Yes Yes Yes in 1993 paper 100% Used routine data sources (ICD codes) to detect late ICH Participants seem to have low prevalence of ICH Skull radiographs not used all Head injury full guideline, appendix 6; second consultation 3

4 Miller et al (1997) 4 Miller et al (1996) 5 is the paper which seems to describe the rationale behind the rule Level 1 This paper tests rule for CT scanning in children and adults: GCS 15, with LOC/PTA and one or more of: Severe headache Nausea Vomiting Clinically depressed skull fracture paper indicates that routine CT is unwarranted. N=2143 GCS 15 and history of LOC Children and adults. Presenting to single USA trauma centre Positive CT scan 65% spec for excluding neurosurgery. 62% spec in excluding any CT abnormal 100% for neurosurgery, but only 65% (90/138) for any CT abnormality Reduces CT ordering by 61% 6.4% Yes = abnormal CT 1996 paper Yes = 1996 paper Yes Yes Not in this paper No. All monitored for 3 hours after injury and then discharged. Paper validates a 4-point decision rule. Unfortunatel their definition of positive C was very wide so the rule sensitivity to any positive C poor. Also no Follow up fo those discharged, and pat without LOC not included. Well constructed validation of rule Haydel et al (2000) 6 Level 1 Well constructed derivation and validation of rule CT for one of the following: Short-term memory deficits Intoxication Trauma Age > 60 yrs Seizure Headache Vomiting Discharge if none of these present N=520 in derivation phase, N=909 in validation phase GCS = 15 Age 3 years and over. attenders at one trauma centre in the USA Abnormal CT-scan findings 25% (22-28%) 100% (95-100%) 76.7% 6.3% Yes Yes Yes Yes Yes 100% - CT diagnosis Concentrates on GCS = 1 Specificity is predictably lo with a high CT ordering ra Head injury full guideline, appendix 6; second consultation 4

5 Richless et al (1993) 7 Level 1 Well constructed validation of rule Livingston et al (2000) 8 Level 1 Well constructed validation of rule Livingston, Loder & Hunt (1991) 9 and Livingston, Loder, Koizel & Hunt (1991) 10 are papers with much smaller sample sizes (N=111 and 138) that reach the same conclusions This study validated the Masters criteria for use of CT in the over 2 age group Low-risk: observation Moderate-risk: extended observation, consider CT, skull series may be helpful High-risk: Neurosurgical consult, emergency CT Rule was standard physical and neurologic exam for all, followed by 100% CTscan. In this study all were admitted for observation, but this was for the purposes of ensuring 100% followup. Objective was to establish safety of early discharge. N=967 GCS 15 Adults and Children over 2 years Single USA community hospital N=2152 GCS and minor head injury with LOC/PTA Adults over 15 years old. 4 level 1 USA trauma centres Abnormal CT Not clear 99.6% 14 CT scans were performed (1.4%) and 23 SXRs (2.4%) Need for neurosurgery Intracranial injury 0% (all those who did not need a test got a test) NPV was 99.9% ( %) for need for a craniotomy 100% Only 1 CT abnormality was found 13% positive CT scans Masters criteria = yes Masters criteria = yes population i.e. any GCS<1 Yes Yes No 93% They do not specify the severity of injury of their No No Yes Yes No 84% of completed the protocol, but the remaining 16% were followed-up and analysed as intention to treat They only had one negativ outcome, but Masters crite was used safely for these thousand. Serious questions about th severity of the population recruited This is an excellent paper demonstrates the NPV of scan. A large number of patient bed days could possibly be saved. Head injury full guideline, appendix 6; second consultation 5

6 Stein and Ross (1992) 11 An earlier paper by Stein and Ross 12 appears in 1990 seems to be the same Level 1 Well constructed validation of rule CT-scan for all with any LOC or amnesia N=1538 Closed head injury admissions GCS No focal neurologic deficits Adults only Admissions to a single American trauma centre Intracranial lesions on CT 0% 100% 100% 13% No (routine practice) No (routine practice) Yes No (review of notes) No 100% CTdiagnosis Prevalence rate is quite hi implies a more severe population Head injury full guideline, appendix 6; second consultation 6

7 Stein et al (1995) 13 Level 2 Well constructed derivation of rule Stein et al (1996) 14 This is a review and data extraction of past papers. Paediatric Retrospective Cohort study. DERIVED RULE: Minimal Closed Head injury(chi) : No LOC/PTA, GCS 15- Discharge with no CT if none of the following risk factors : -Extracranial injuries -Age<2 with repeated vomiting -No reliable transportation or reliable observation at Home -Anticoagulationn or medical condition increasing risk -Palpable depressed skull fracture. 1 or more seizures Suspected child abuse Persistent headache, nausea, vomiting etc.. If risk factor present admit and CT if symptoms persist. Miild CHI: GCS14 or GCS15 and LOC <5 mins, event amnesia N= 2,533 fully reviewed from a population of 12,809 from whom some data was obtained All GCS scores Children under 19 years old Single USA university hospital children assessed, then defined population fully reviewed Intracranial lesion, Neuro surgery Glasgow Outcome Score at 6 months 81% sensitivity of rule High sensitivity if you use as a denominato r. To use this denominato r we must be satisfied that the follow up of the 10,276 minimal head injury was adequate (see notes) 100% Proposed rule would lead to 7% CT ordering rate. 2.6% of mild head injuries needed neurosurgery. (1.9% of GCS 15) 0.01% neurosurgery for Minimal head injury ( 1 case in 11,907) Yes No No No No All mod, mild and minimal HI with high risk factors were followed up at 48H and 6 weeks (80% successful F/U) Of the 10,276 minimal CHI who were discharged no F/U protocol was described but it was stated that none deteriorated, were readmitted or needed neurosurger y. A survey of a sample of 734 of these was performed (78% F/U success) to look at morbidity in this minimal CHI group They state that during the study period all children w mild and moderate CHI ha CT scan and that many o those with a minimal CHI h a CT scan. It is unclear as to what proportion of were seen according to their rul although the implication is they were. Follow up of the 10,276 wa retrospective and seems t have consisted of checkin readmission, or surgery at institution. - CT scan all. If neg and none of above high risk factors discharge. Mod CHI: LOC > 5mins, GCS 9-13 or focal neurology. Head injury - Immediate full guideline, CT and appendix 6; second consultation 7 admission

8 Stein and Spettel (1993) 15 This is a univariate analysis of neurological assessment and therefore of limited use in our search for a decision rule Hsiang et al (1997) 16 Level 2 Well conducted exploratory study Concludes that N=685 neurological assessment either by GCS or by Reaction Level Scale (RLS85) is not adequate to determine risk of ICH. Recommends CT for all with LOC / PTA Derived rule: High-risk mild head injury is GCS and GCS 15 with acute radiographic abnormalities. (Including CT findings) Mild head injury is the remaining GCS 15. GCS Age range not stated? Adults only Patients who had CT at single trauma centre. USA.. N=1360 GCS admitted to hospital. Patients over 11 years old Single Hong Kong Hospital Intracranial abnormality on CT scan Abnormal CT Skull fracture 6 month GOS. 72% specificity for neurosurger y after radiographi c imaging that includes SXR and/or CT scan 100% sensitivity for neurosurge ry CT rate reporting the inabi of neurological assessmen extracted from case record 100% 18% ICH Yes No No No No No Retrospective study with 1 predict ICH. No other symptoms or signs were 62% 6% of had bad outcome Yes Yes No No Yes Yes. 6 month Glasgow Outcome Score in all Study is of limited use in constructing a comprehen rule for CT scanning. Unfortunately this rule is to predict outcome. It require to undergo CT scanning before categoris them. Head injury full guideline, appendix 6; second consultation 8

9 Jeret et al (1993) 17 Level 2 Well conducted exploratory cohort study. This is an exploratory cohort study that looks at a number of prognostic variables. The paper reports that 4 variables predict abnormal CT: older than 60 years, white race, BSF signs and motor vehicle or assault cause. N=712 GCS 15, with LOC or amnesia. Adults 18 and over 2 USA hospitals Neurosurger y, abnormal CT Abnormal neurology assessed by a neurologist for all 100% 9.4% abnormal CT rate 0.3% neurosurger y with a history of L or amnesia who have norm neurologic signs and perfo well on tests in A&E may s indicate that further progno Yes Yes No No Yes 100% Authors state that GCS15 develop ICH. Seems to variables required. No item or combinations could classify 95% of correctly. Authors conclude that CT may be indicated for all types of. Nagy et al (1999) 18 Level 2 Well conducted exploratory cohort study with 100% CT rate. Rule: All GCS 15 presenting with LOC/PTA should undergo CT scanning. If this is normal then they are safe to be discharged N=1,170 GCS 15 with LOC/ PTA Adults USA level 1 trauma centre Intracranial abnormality on CT 100% of No positive discharge outcomes excluding for ICH after admission negative CT and deterioratio n 100% 3.3% (39 ) abnormal CT 0.4% (4 ) had neurosurger y Yes Yes No No No All with a normal CT were then observed for 24 hours. No other follow up after discharge There is no analysis of pat who do not have LOC/PTA in the specific patient grou that they have selected thi provides good fo safe discharge. Head injury full guideline, appendix 6; second consultation 9

10 Gomez et al (1996) 19 No universal Gold Standard applied Recommends CT for all GCS 13, 14 and SXR for LOC and PTA. N=2484 GCS Does not test a rule and Age over 15 follow-up results of non- CT and non x-ray Attendance is not recorded at single Spanish hospital CT abnormality Neurosurger y or death 7.5% 0.8% of had neurologic deterioration 7 had surgery (0.2%) 11 died (0.3%) GCS not 15 after 4-6 hour and SXR the rest but this w Yes No No No Yes No Recommends CT in all wit not tested Dunham et al (1996) % Gold Standard of either CT or Follow-up was not applied They state that all minor head injuries should have CT but state that age, GCS, cranial soft tissue injury increases the risk of getting an ICH This study does not examine consistent application of a rule certain did not have CT N=2587 GCS13-15 Age over 14 Patients attending single USA trauma centre ICH on CT 91.3% 7.2% Yes Yes No No No Follow up of non-ct not included Paper of limited use, poorl presented results. Non-CT not reported. Head injury full guideline, appendix 6; second consultation 10

11 Harad et al (1992) 21 Nonconsecutive study. They recommend CT for all with minor head injury. N=1875 Outcome: that abnormal CT attended only neurosurgery 497 who had CT were included in the study (Criteria for CT was LOC, GCS>13 focal deficits, skull fracture, pupils) 100% Focus is only on those with CT Yes No No No No No follow up of non-ct Study of limited use to us All GCS Age of not described probably adults only Patients scanned at a level 1 USA trauma centre. Nonconsecutive Head injury full guideline, appendix 6; second consultation 11

12 Servadei et al (1993) 22 Servadei, Ciucci et al (1995) 23 reports similar results same design problems Servadei, Vergoni et al (1995) 24 reports a case series Servadei et al (1989 reports a case series) as unclear reference standards If GCS and patient is 14 years or more then skull x-ray is performed. Positive skull fractures then receive CT-scan. If no fracture consider discharge Children less than 14 years are referred to a regional hospital with 24-hour CT for observation and/or CT. N=423 adults and 83 children in protocol free period N=859 adults and 191 children in period with protocol Adults included if GCS And brief LOC, or Skull fracture Children included if symptomatic but not if in stupor, coma or focal neurology. Asymptomati c children not included Attendance at single Italian Hospital Positive CTscan. Mortality (followed up through routine sources) Not possible to produce for this design But of 859 the specificity of admission Vs Non admission is 34% 23 Not possible to produce for this design Although for the 859 in the protocol driven group 2 out of 72 abnormal CTs were missed. Sensitivity = 97% 23 Overall population results not reported but with protocol 30% of had CT scan 23 Overall population results not reported but of 859 reported 72 positive examination s found = 8% 23 Yes in their 1988 Paper Yes in their 1988 paper Yes No No Not clear but Very poor paper essenti they report 2 figures not included, poor cases of design focus almost enti readmission on cases. that had abnormal CT scans on rescanning cerebral contusions, and a 4x5cm frontal contusion. both treated conservativel y Survey of deaths also done none found Probably non consecutive Head injury full guideline, appendix 6; second consultation 12

13 Servadei F, This is a review on behalf of the WHO Neurotrauma Collaborating Center Their recommendations are as follows : Teasdale GM et al (2001) 25 Low-risk mild injury are those with a Glasgow Coma Score (GCS) of 15 and without a history of loss of consciousness, amnesia, vomiting, or diffuse headache. The risk of intracranial hematoma requiring surgical evacuation is definitively less than 0.1:100. These can be sent home with written recommendations Review Schynoll et al (1993) 26 Exploratory Cohort study but were not a consecutive cohort of head injured. Medium risk mild injury have a GCS of 15 and one or more of the following symptoms: loss of consciousness, amnesia, vomiting, or diffuse headache. The risk of intracranial hematoma requiring surgical evacuation is in the range of 1-3:100. Where there is one computed tomography (CT) scanner available in an area for 100,000 people or less, a CT scan should be obtained for such. If CT scanning is not so readily available, adults should have a skull x-ray and, if this shows a fracture, should be moved to the 'high-risk' category and undergo CT scanning High-risk mild head injury are those with an admission GCS of 14 or 15, with a skull fracture and/or neurological deficits. The risk of intracranial hematoma requiring surgical evacuation is in the ran 6-10:100. If a CT scan is available for 500,000 people or less, this examination must be obtained. Patients with one of the following risk factors - coagulopathy, drug or alcohol consumption, previous neurosurgical procedures, pretrauma epilepsy, or age over 60 years - are included in the high-risk group independent of the clinical presentation 9 variables yield high rate of abnormal Ct : alcohol, amnesia, LOC, pupils, babinski, focal lesion, GCS<15, cranial nerve lesion, basilar # N= 264 All GCS grades (51 under GCS 15, 17 +ve CT)) Patients, all ages 2 USA hospitals. Not consecutive attenders only those undergoing CT Abnormal CT scan as decided by 2 radiologists, if either feel that there is an abnormality. 100% 32 positive CT, 12% for CT scan. Does not pro data on what the sensitivit would be. 10 % of none of their high risk crite Yes Yes No No Yes No Identifies 9 high yield crite and specificity of this rule Head injury full guideline, appendix 6; second consultation 13

14 Nelson et al (1992) 27 This paper is not directly relevant to our review. Murshid et al (1994) 28 Murshid et al (1998) 29 report very similar data Exploratory cohort study but not a consecutive cohort of those attending hospital. This paper looks at Head CT, Thoracic CT and Abdominal CT so Head CT is a sub analysis. Rule is that GCS 15 pts can have their CT safely delayed (but must be done) Does not provide data for the non-ct Conclude that SXR is unnecessary and after careful examination CT should be performed. Criteria for CT not given. N= 374 All GCS scores Adults only Level 1 USA trauma centre blunt trauma of all causes N=566 GCS All ages Single Saudi Arabian Hospital Selected cases as its only those who were admitted and admission criteria are unclear. Abnormal CT Abnormal CT, skull fracture on SXR, neurosurgery and death 71% Not possible to calculate Not possible to calculate Not possible to calculate Yes Yes No No No No Paper is not relevant and the recommendations Yes No No No No No follow up This study is a selected gr of limited use to us. Head injury full guideline, appendix 6; second consultation 14

15 Holmes et al (1997) 30 Level 2 Evidence Well conducted exploratory study in GCS 14 with 100% CT rate Borczuk et al (1995) 31 Level 2 Well conducted study. Query over the truly consecutive nature of the investigated Their conclusion is the Miller criteria, which aims to stratify the GCS 14 group into high and low risk is unsafe. The Miller criteria imply that GCS 14 with no soft-tissue injury and neurologic improvement can be released. They imply that all GCS 14 should be scanned. Identified High risk factors to be: Cranial soft tissue injury Focal neurology Basal skull # signs Age >60 N=264 GCS 14 only Adults Level 1 USA trauma centre Nonconsecutive receiving CT only CT were studied N=1448 GCS 13-15, Adults Level 1 USA trauma centre who had undergone CT CT scan abnormality CT scan Neurosurgica l intervention 46.2%% for rule as applied to derivation set 91.6% for rule as applied to derivation set 100% CT 13.2% Yes rate in this abnormal CT (Miller) study 1.5% required neurosurger y 100% 8.2% abnormal CT, 0.8% neurosurg. Yes (Miller) safety of the rule, the Mille Criteria in GCS 14 patient The paper only focuses on who received CT, demonstrates the failure o Yes Yes No None This is a paper rejecting T is still valuable as it these criteria to identify with ICH. Selected cohort of states that all with injuries above LOC or PTA always undergo CT and th setting out only to investig GCS 14, it may be consecutive cohort of thes retrospectively and comme who had CT, but as the p assumed that this is a Yes No No No No None This paper derives a rule on its performance. These were selec retrospectively from the ED and Radiology records and only who received were included. However th state that they employ a lib and rigidly applied CT poli and therefore these patien represent a consecutive co of non-trivial injury Head injury full guideline, appendix 6; second consultation 15

16 Moran et al (1994) 32 Level 4 Exploratory cohort study of a specific population of those transferred by airambulance. Poorly applied gold standard Immediate CT-scan for all GCS13-15 with LOC or suspected skull fracture. N=200 GCS Adults and children over 6 years Single USA hospital Nonconsecutive. Only study of who were transferred to them by airambulance Positive CTscan demonstrating the elevate fracture (5/9 versus 3/192) Underpowered to make th 48% 4% No No No No No None Paper s only worth is risk associated with skull conclusions. Head injury full guideline, appendix 6; second consultation 16

17 Arienta et al (1997) 33 Level 2 Evidence Exploratory cohort study. Universally applied Gold Standard which was in most cases a follow up telephone call 4 different groups: 1. GCS=15, no LOC, currently alert and no neurologic problems, absent or minimal subgaleal swelling (this seems like a definition of trivial. Patient is released into care of a family member with written instructions 2. GCS=15, transitory LOC, patient awake, oriented and without neurologic deficits. Amnesia, one episode of vomiting, significant subgaleal swelling. Neurologic evaluation and CT-scan. If not CT available, skull x-ray and observation for 6 or more hours if x-ray negative. CT-scan if positive skull x-ray 3. GCS 9-15, impaired consciousness, uncooperative, neurologic deficits, otorrhagia/otorrhea, rhinorrea, signs of basal fracture, seizures, penetrating or perforating wounds, in anticoagulant therapy, affected by coagulopathy, previous intracranial operations, epileptic or alcoholic. CT-scan and neurologic evaluation. 4. GCS 3-8, resuscitate and CT-scan N=10,000 All GCS scores Adults and children over 6 years Single Italian hospital Patients retrospectivel y selected from clinical records consecutive. Intracranial lesions 90% 100% specificity in sensitivity their in their derivation derivation set, not set, not tested in a tested in a validation validation cohort cohort 59.2% 1.5% Yes No No No No 99% Retrospective review used classify, Head injury full guideline, appendix 6; second consultation 17

18 Shackford et al (1992) 34 Exploratory cohort study with inconsistent reference standards stated the paper is more of an audit of current practice, although they do estimate the sensitivity and specificity of a CT alone strategy. They end up recommending 100% CT. N=2766 GCS Adults and children 7 USA trauma centres During study period 9626 were seen with any level of head injury were selected as minor therefore but only with strict criteria for MHI Relevant positive CT (excluding fracture) Craniotomy Not possible to produce for this design Not possible to produce for this design 78.3% 17 % relevant positive CT (468/2766 9% intervention rate 256/2766) Yes No No No No None This is an entirely retrospe study used to derive a 100 CT rule. The study quality Follow up poor clinicians reviewing protocol not notes, which are most like stated but 3 dubious quality. Very high who abnormality rate were readmitted are described so some form of checking for readmission may have been done Mohanty et al (1991) 35 Nonconsecutive exploratory cohort study. stated this is a retrospective study of CT only. They state that low-risk require observation alone. Low-risk seems to be: history of head trauma, 18 years or older, GCS 14-15, no decline in neurologic status, absence of any focal, sensory or motor neurologic deficit, absence of any obvious signs of BSF. N=348 GCS Adults Single USA regional trauma centre Nonconsecutive selected from 4 month periods in 1986, 97, 98 Abnormal CT Not possible to calculate 3.4% = Yes No No No No None Focus only on CT abnormal CT poor quality study Head injury full guideline, appendix 6; second consultation 18

19 Rosenorn et al (1991) 36 Exploratory cohort study but without universally applied reference standards Audit of practice describes the utility of skull x-ray N=1876 GCS 15 Adults and children Single Danish Hospital Nonconsecutive ICH development 0.5% Not applicable significant difference in the fracture who had a skull x- Also no significant differen ICH development between those with and without sku Yes Yes No No No None Demonstrates that there is of development of ICH in with or without sk ray. Inconsistent application of reference standards and n follow up. No guidelines for SXR wer used and any discharged without a SXR were excluded from the st Head injury full guideline, appendix 6; second consultation 19

20 Viola et al (2000) 37 Tomei et al (1996) 38 Inconsistent reference standards Group 0: GCS 15, no LOC/amnesia/headach e/vomiting, no other risk factors should be discharged Group 1: GCS 15 one or more from LOC/amnesia/headach e/vomiting, no other risk factors need radiology and clinical observation Group 2: GCS 14 with or without LOC/amnesia/headach e/vomiting and with or without other risk factors need radiology and clinical observation and admission N=4536 GCS Adults and en over 12 years old Single Italian Hospital Abnormal CT scan 86% 100% (3864/4492) 19% 1.9% No No Yes Yes 4078 were clinically observed for 6 to 12 hours and then discharged, without any further follow up. Admitted were reviewed within 6 months No follow-up of non-admitt from this paper, therefore specificity is ope question. Group 0-1R: GCS 15 with or without LOC/amnesia/headach e/vomiting, but with other risk factors. Not clear from the paper how treatment for these differ. NB - Risk factors here refers to coagulopathy/alcoholis m.epilepsy/abuse of drugs/previous neurosurgical operations/disabled elderly. Head injury full guideline, appendix 6; second consultation 20

21 Uchino et al (2001) 39 Small retrospective exploratory cohort study. This N=90 paper examines the utility of GCS in GCS 13-15, classifying. All had CT or MRI. Adults aged >13 years Single Japanese Hospital Abnormal CT attempts to demonstrate th GCS alone cannot rule ou ICH. They also conclude t MRI should be performed parenchymal lesions cann imaged with CT. Study is 100% 14% Yes Yes No No No No This is a small study that with GCS 14, as underpowered for these conclusions. Gutman et al (1992) 40 Nonconsecutive Cohort study This is an exploratory cohort study, which looks at a number of prognostic variables. They conclude that age, GCS, injury due to a fall, injury due to motorvehicle occupant, pupil inequality are best ICH predictors. N=1039 admitted with a head injury All GCS scores Adults >15 years old Single Canadian regional trauma centre Operable ICH time indicating that age, G injury due to a fall, injury d pupilary inequality are the 100% 27% Yes Yes No No Yes No Another prognostic study, to motor-vehicle occupant ICH predictors. Results influenced by the more se patient profile. Poorly presented results. 2/3rds of in their s had been referred from oth hospitals No follow up described aft discharge Non- as 2/3rds of had been referred by other hospitals therefore pre selected Head injury full guideline, appendix 6; second consultation 21

22 Taheri et al (1993) 41 Retrospectiv e exploratory cohort study with no universal gold standard Exploratory cohort study designed to identify those with minor head injuries that can be safely discharged from A&E. They state that: GCS 15, no deficit except amnesia, no signs of intoxication, no of BSF on clinical exam, no linear fracture on skull x-ray. N=310 fully assessed out of 407 who were reviewed GCS 15 Adults over 14 years old Single USA trauma centre ICH Conclusion is that follow up data. Retrospec study, and highly selected 55% 23% Yes No No No No None Small study, poorly presen meeting certain criteria ca safely discharged, but no patient group. Vilke et al (2000) 42 Very small non consecutive study Exploratory Cohort study 3 Patients had ICH, 2 Had abnormal neurology but one Had no neurology. Conclusion is that full neurological examination is not adequate to exclude ICH. Porchet et al This is a review, no (1998) 43 original data N=58. GCS 15 with LOC/PTA Sober adults Single Canadian hospital. Nonconsecutive Acute intracranial injury on CT 61% 66% sensitivity of neurologica l exam in predicting ICH 100% 5% ICH Yes Yes No No No No Underpowered study and therefore of limited value Head injury full guideline, appendix 6; second consultation 22

23 Pasman et al (1995) 44 Pasman et al (1992) 45 Validation cohort study but without universal gold standard. Hung et al (1996) 46 Not clear that a gold standard was universally applied and cohort consists only of those admitted for head injury, not whole head injury population seen by the hospitals Retrospective cohort study to validate the Masters criteria in a Dutch setting. Rule: The master s criteria are safe in the low risk category. In the high and moderate category CT scanning should be used rather than SXR Rule: Patients who have either lost consciousness or have a skull fracture are at increased risk of surgically significant intracranial haematoma N=1218 All GCS groups Adults 1 University hospital in Holland N=28,500 All GCS scores Average age 35. No further details given Patients admitted to hospitals in Taipei city and Hualien county hospital in Intracranial haematoma Surgically significant Intracranial haematoma neurosurgery 37% of Low Vs (Mod or High risk) in the rule Specificity of LOC and absence of skull fracture in excluding ICH is 77% 100% Sensitivity of LOC or Skull fracture in detecting ICH is 75% It is 1.6% unclear as intracranial to what haematoma rate of CT scanning the study recomme nds Does not give advice for CT scanning 9,038 (31.9%) had intracranial haematoma on CT. 3,348 (11.7%) had a craniotomy. Yes (the Masters criteria) Yes Yes Yes No No No followed up after discharge. No No No No No follow up protocol was described The in this study d not actually undergo management by the Maste criteria. Thus only 70% of in the Mod group received a SXR. Also ther was no follow up after discharge. In the Mod group they foun 1 patient with an ICH but without skull fracture. They thus state that CT is super to SXR but do not actually recommend a CT for all in the Mod category (which would give a CT ordering rate of 33%) A patient without LOC or a skull fracture still had a ris of 5.5% for surgically significant intracranial haematoma. In GCS group skull fracture increases the risk ICH by 5.5 times Paper of limited value Head injury full guideline, appendix 6; second consultation 23

24 Mikhail et al (1992) 47 Small study with non universal gold standard, Prospective Exploratory Cohort study Concludes that Age >40, and headache are associated with intracranial injury in the GCS group. proposed N=113 GCS Adults only Single USA level 1 trauma centre consecutive Intracranial injury on CT scan Neurosurger y proposed proposed 35 scans performed in this study 8 with ICH on CT (7%) 3 had neurosurger y Yes Yes No No Yes 83% follow up at 4 weeks by telephone Underpowered study. Entr criteria of complaint of hea injury and GCS 13-15, loo very unlikely to produce a prevalence of 7% ICH. Lik that further criteria e.g. LOC/PTA were used to exclude trivial injury, but these were not mentioned Head injury full guideline, appendix 6; second consultation 24

25 with evacuation of Teasdale et al (1990) 48 Level 4 Case-control study Fully conscious without any indication for skull x-ray: discharged (criteria for a Skull X-ray are not given) Negative skull x-ray : discharged Positive skull x-ray : urgent CT Patients with impaired consciousness or neurologic signs: urgent CT Negative CT : observed in hospital until they have recovered A&E PATIENTS: N=8406 All GCS scores Adults, and children under 14 compared as 2 groups 3557 from all hospitals in Scotland in a 2 week period in 1974, 768 pts from Glasgow, 710 pts from Teesside, 3371 pts from Monklands Need for neurosurgery Proposed Not possible rule would to calculate lead to for this 7% CT design. ordering rate a case-control comparison historical data point to the consciousness as key risk factors. In fully conscious adults they state that the r someone with neither skul fracture nor history of LOC same for children. Study i undermined by the design Yes No No No Yes Not relevant This retrospective design i The authors indicate that role of skull fracture and history of altered goes from 1 in 31,370 for 1 in 29 for someone with both risk factors. Risk factors are said to be the Nonconsecutive NEUROSUR GERY PATIENTS: N=1007 All GCS scores Adults, and children under 14 compared as 2 groups Patients from Glasgow neurosurgical unit from Head injury full guideline, appendix ; second consultation 25

26 Tsai et al (1994) 49 Level 4 Retrospectiv e exploratory cohort study with poor reference standards Rule proposed: CT scan for LOC / PTA. Progressive neurologic abnormality, GCS <13. People with normal CT can go home. N=186 GCS Adults Attending 1 Taiwanese Hospital, Nonconsecutive, Abnormal CT scan Neurosurger y Unable to calculate as paper states that there were asymptomat ic and delayed onset haematoma s but did not give any further details of numbers Unable to 4% calculate as paper states that there were asymptoma tic and delayed onset haematom as but did not give any further details of numbers 22% abnormal CT 6.5% neurosurger y Yes No No No No Yes but no details given other than stating: This recommenda tion is not foolproof asymptomati c and delayed onset haematomas did occur The Patient group was hig selected: from 4760 record 186 were found w were GCS and had CT scan requested. Criter for CT were LOC/PTA, foc neurology, depressed or open skull fracture, pupil inequality, deterioration in mental status. This paper has many methodological flaws. It s reporting of results is incomplete with regard to t total number of haematom found in the study period. Sharma et al (1994) 50 Validation cohort study but with inconsistent reference standards Retrospective validation cohort study. Management Protocol: Admission: History of trauma and, LOC, bleeding from ear, nose or mouth, vomiting or skull fracture on SXR CT scan: GCS<8 with no eye opening for 6 hours, deteriorating sensorium, focal pupil or limb signs, coma, unresponsive to verbal commands for >24 hours, seizures, hyperpyrexia and neck rigidity. Cummins (1992) 51 Irrelevant paper N=312 All GCS grades Adults and children Attending 1 Indian Hospital Abnormality on CT scan Referral to neurosurgery Not reliably obtainable Not reliably obtainable 16% of the 87 children 22 of 87 No abnormal CT 25% ICH or cerebral oedema This paper is of little value No Yes No No All None of those admitted or with residual discharged were followed deficits or on if asymptomatic at anti discharge. Only 83 scans convulsants of 312 were performed in seen. total so no reliable gold standard. Head injury full guideline, appendix 6; second consultation 26

27 Frush et al This is a review of poor (1998) 52 quality. Otte et al This is a case report of (1998) 53 disability after head injury Herbert et al This is a review not (2000) 54 for inclusion. Finizio et al This is a nonconsecutive case series (1992) 55 of 21 operated Extradural Haematomas in children. reporting fracture rate and location of haematoma. Therefore not relevant to our review. Packard et al Review of post- (1993) 56 concussion syndrome, 1860 s to present day - Irrelevant article. Reinus et al This is not exclusively a (1994) 57 head injury paper Head injury full guideline, appendix 6; second consultation 27

28 Cigada et al (1999) 58 : unclear patient selection policies. Power problems Paper examines the impact of guidelines on minor head injuries in a small cohort of Paper is in Italian First Cohort N=257 GCS Adults Single Spanish hospital Second cohort N=221 GCS Adults Single Spanish hospital Sturloni et al Irrelevant to the review: (1997) 59 in Italian Ciccarese et al (1998) 60 Level 2 : unclear patient selection policies Rule implemented in this study: Group 0: GCS 15, no symptoms or risk factors and the possibility of being monitored at home. Group 1: GCS 15 and one or more symptoms N= 6,600 All GCS Adults Single Italian Hospital 189 lesions found Yesderived from other authors reports unclear Yes Yes No Group 2: GCS 14 Group 0 may be discharged without investigations Group 1 and 2 should have a CT scan Head injury full guideline, appendix 6; second consultation 28

29 Ingebrigtsen et al (1995) 61 No universally applied Gold standard. Rule: In presenting with GCS14-15 and no neurological deficits and normal CT, these can safely be discharged N= 146 GCS and no neurological deficits. 128 LOC Adults Single Swedish Hospital Intracranial lesions on CT No positive cases after normal CT No positive cases after normal CT 67% in the study 5% intracranial lesions Yes Yes No NO No unclear Savastio et al (1991) 62 : unclear patient selection policies High risk criteria: Basilar fractures (otorrhea, rhinorrhea, focal neurology, retroauricular haematoma), LOC Moderate risk: LOC, Amnesia, multiple trauma, possible skull penetration. N=4262 All GCS grades Adults 1 Italian hospital Intracranial sequelae on CT Skull fracture High risk criteria 100% sensitive for intracranial sequelae 0.7% Yes Yes No No No Culotta et al This is a study of neurobehavioural outcome rather than risk of Intracranial (1996) 63 pathology and therefore not relevant to this search Hofman et al (2000) 64 This is a meta-analysis of a single variable fracture, and intracranial pathology. No new rule proposed Kelly et al (2000) 65 Irrelevant to this review Lucchi et al (1995) 66 Irrelevant to this review Head injury full guideline, appendix 6; second consultation 29

30 Shaabat et al Irrelevant to this review (2001) 67 Kelly et al This Is a paper comparing a cohort of 100 who had CT (1988) 68 and MR scanning. Only 3 had both within 3 days of injury. Conclusions are that CT are superior in the acute situation but MR scanning is superior thereafter. This paper is of interest but largely irrelevant to our clinical question regarding guidelines for acute head injury. DATA EXTRACTION FOR PAPERS DESCRIBING RULES FOR HEAD CT SELECTION: NON- ADULTS Names and level Rule description Participant s Outcomes Specificity Sensitivit y CT Prevalenc ordering e rate Derived using primary data Derived using prospec t. data Validate d using primary data Validated using prospect. data Multivariate Follow-up modellin g Notes Hahn et al (1993) 69 Level 2 Exploratory cohort study with good reference standards Advise CT in all children with minor head injury, (i.e. non trivial, pt. Has LOC headache vomit reduced GCS) and hospital observation. They also recommend follow up CT hrs after injury. N=791 CCS (children s coma score) Children age 0-16 Single level 1 USA children s trauma centre Abnormal CT, Skull fracture on SXR, neurosurger ydeath 80% 13% required neurosurger y Yes Not clear No No No All followed up This is a prospective observational study followe by guideline construction. They did not see if the pati deemed safe for discharge came to harm so the full guideline has not been assessed in this study. Head injury full guideline, appendix 6; second consultation 30

31 Greenes et al (1999) 70 Level 2 Well conducted exploratory cohort study All infants under 3 months need radiographic imaging (CT or SXR for haematoma only). 3 mths to 2 years, if asymptomatic and no scalp haematoma discharge N=608 All GCS scores Infants under 2 years old Single USA paediatric trauma centre ICI defined on CT 31% 5% had ICH Yes Yes No No No Yes all Very big study in the under followed up age group. by telephone Head injury full guideline, appendix 6; second consultation 31

32 Greenes et al (2001) 71 Level 2 Well conducted exploratory cohort study Exploratory Cohort study of consecutive asymptomatic infants attending single paediatric trauma centre. Patients excluded if any of the following: LOC lethargy, irritability, depressed mental status, bulging fontanel, focal neurology, reduced GCS, Palpable skull fracture Derived Rule: Imaging required if score below is 3 or above: (Imaging means SXR for all asymptomatic followed by CT for all Skull fractures.) N= 422 All GCS scores Age 0-24 months. Single USA paediatric trauma centre Intracranial Injury, defined as cerebral contusion, cerebral oedema, or intracranial haematoma. Skull fracture on SXR or CT. 40% for excluding ICI, amongst the 172 who had imaging 100% for detecting ICI Imaging rate of 35% 3% ICI 11% Skull fractures. Only 1 patient had a neurosurgica l intervention. Yes Yes No No Yes 98% of successfully received a F/U telephone call at 2 weeks Note only 172 of the 422 had a CT or a SXR The rest were not imaged a all. (41 CT and 96 SXRs). Specificity only obtainable those 172 who ha imaging. 250 excluded from this calculat Provides a rule for the asymptomatic 0-2 years ag category. NAI were included their study. 0 risk points for any of: Over 12 mths, no scalp haematoma, frontal location. 1 risk point for each of: 6-11 mths, small scalp haematoma, occipital location. 2 risk points for each of: 3-5 months, Medium scalp haematoma, Temporal/parietal location. 3 risk points for each of: 0-2 months, large scalp haematoma, Range of scores is 0-8 points Head injury full guideline, appendix 6; second consultation 32

33 Chan, Yue et al (1990) 72 Chan, Mann et al (1990) 73 Level 2 Well conducted exploratory study. Prospective cohort does not have universally applied gold standard Children with either a skull fracture or a history of impaired consciousness have an elevated risk of ICH and should have immediate CT. Children with a history of impaired consciousness alone should have immediate CT. RETROSPE CTIVE COHORT: N=12072 All GCS scores Children under 16 years Single Hong Kong university hospital ICH development Not clear 1.3% = ICH in retrospective cohort 1.1% in prospective cohort Yes No Yes Yes Yes In This study follows the sam retrospective lines as the Teasdale study cohort 100% indicating the importance o admission skull fracture and LOC. rate, then no Validation study has poor follow up after discharge. follow-up. The prevalence rate is very low leading to large confidence intervals. Prospective cohort: 35% admitted and followed up at 3 months others not followed up PROSPECTI VE COHORT N=1178 Adolescents (11-15 years) All GCS scores but only 21pts less than GCS 15 (6 ICH) Single Hong Kong university hospital Head injury full guideline, appendix 6; second consultation 33

34 Roddy et al (1998) 74 Level 2 Exploratory cohort study in minor head injury after normal CT scan Gruskin et al (1999) 75 Level 2 Well conducted exploratory cohort study Rule: Patients following minimal head trauma with normal CNS exam and normal CT scan may be safely discharged Derived rules: Low risk: Fall<0.9m, no history of neurologic symptoms, normal scalp examination. - May be safely discharged without investigation N=62 GCS 15 only Children under 16 Single US level 1 trauma centre consecutive N=278 All GCS scores Children under 2 years old Attending tertiary paediatric emergency hospital on hospital database Delayed ICH No positive outcomes Presence of skull fracture or Intracranial No positive 100% outcomes in the study 16% 100% 94% if all that are not low risk are scanned 0% Yes no no no no All were followed up until discharge. No further follow up thereafter. 4.3% intracranial injury. Yes From 277 children admitted the study period, 62 met th strict entry criteria. Low power study that tries exclude late deterioration No No No Yes Protocol not described but states that 4 returned to hospital, one had haemotympa num but normal repeat CT and the other 3 were discharged after reevaluation This study identifies a sma set of (43 out of 27 who may be safely discharged. Head injury full guideline, appendix 6; second consultation 34

35 Levi et al (1991) 76 This study is not a consecutive study of the population of all presenting with Head injury. Paper concludes that age and severity of injury affect outcome and that the presence of a skull fracture is unrelated to the presence of intracranial pathology. N=653 All GCS scores (41% GCS under 12) Children under 14 years Single Dept neurosurger y Israel. cohort of admitted to the dept of neurosurger y. But non consecutive cohort of all presenting with a head injury. Presence of Skull fracture. Any CT abnormality Disability outcome at 3 months 26% specificity in SXR predicting ICH 68% sensitivity in SXR predicting ICH given 17.5% craniotomy rate 34.6% abnormal CT rate 43 deaths Yes Yes No No No High follow up rate at 3 months (>98%) This is a selected group in only who were selected for admission wer studied. No data is given o whether any not admitted had a negative outcome. Head injury full guideline, appendix 6; second consultation 35

36 Murgio (2001) 77 Evidence Nonconsecutive study Multicentre Exploratory cohort study. Concludes that SXR is unwarranted but no rule for the management of head injuries in children is proposed N=4690 GCS Children 0-15 years Patients attending hospitals in Argentina, Brazil, France, Hong Kong, and Spain. Abnormality on CT scan Neurosurgic al Intervention Glasgow outcome score on follow up proposed proposed 14% CT rate in study 7 deaths Yes 81 had neurosurgica l intervention 5.6% pathological CT scan rate Yes No No No Follow up at Large study but cohort is 2-weeks and highly selected from multip 2 months. 79% face to face, and 21% by telephone hospitals in multiple countr some of whom provided ve small numbers, so is this tr representative of the full m head injury population attending emergency departments? Lloyd, Carty et al (1997) 78 The application of the Gold standard of CT scan was dependent on whether the patient had a skull fracture on SXR or was admitted Recommend SXR only for suspected NAI, depressed fracture or penetrating injury. CT should be Investigation of choice All GCS scores who were admitted r had skull fracture Children under 16 Single UK paediatric trauma centre Nonconsecutive N=883 Nonconsecutive Abnormal CT, Skull fracture on SXR, neurosurger y and death 156 CT scans seems like 1.7% Not clear as results for total population not reported Yes Yes No No No No follow up and 6011 who had negative SXR not followed up They did not test their rule no SXR and only CT. Rule CT not explicitly derived Head injury full guideline, appendix 6; second consultation 36

37 Adams et al (2001) 79 Patients identified from a trauma database, no universal gold standard of CT or follow up Wang et al (2000) 80 Highly selected prospective exploratory cohort study They recommend SXR and CT on all children but if GCS 15 they do not need to be admitted Recommend CT scan for all GCS 13 and 14 N=1033 GCS 15 and admitted for head injury Children under 18 Patients entered in the National Pediatric Trauma registry USA Nonconsecutive N=209 GCS Children age under 15 Attending 13 trauma centres serving Los Angeles USA Non in the sense that this cohort was selected from a cohort of Abnormal CT-scan Abnormal CT, neurosurger y 37.4% Overall population results not reported. This cohort had 86% CT rate No neurosurgica l interventions out of 1033 Overall population results not reported 27.4% abnormal CT rate with GCS and no LOC limit Yes No No No No No follow up Very small subset of patien value to us. Yes Yes No No No No This study is GCs 13, 14 o limited value to us Head injury full guideline, appendix 6; second consultation 37

38 Dietrich et al (1993) 81 Only selected for CT were included in this study, therefore nonconsecutive. Recommends CT for all GCS<15, and all GCS 15 if there are any symptoms (i.e. LOC nausea, vomiting, seizures etc) N=322 All GCS scores (50 under GCS 15) Children aged 0-16 years Single USA children s trauma centre ICI on CT scan concluding that there are n reliable rule to safely exclu 100% 12% Yes Yes No No No None Large study in children some children from scanni Non-consecutive Nonconsecutive Head injury full guideline, appendix 6; second consultation 38

39 Quayle et al (1997) 82 Exploratory cohort study but see notes for details of study weakness. Study found association with skull fracture, LOC for 5 mins, altered mental status, and focal neurology. But absence of any of these factors does not exclude ICH N=322 All GCS scores Children under 18, Single USA paediatric trauma hospital Positive CT scan 98% 8% = ICH Yes Yes No No Yes but see following text Yes by telephone 3-7 days later. The commentary below wa sent by TARN to us about study Prospective study compari usefulness of skull x-ray an other clinical features in identifying intracranial injur CT used as gold standard. children aged from 0 to 18 years. Huge difference between 321 in sample an not entered in terms of admission rates (3% vs. 26 suggesting that the less clinically serious non-trivia head injuries are being ignored. This could affect t estimates NPV and PPV by increasing the number of fa positives (sign or symptom present but no IC injury) or increasing the number of tr negatives (sign or symptom not present and no IC injur Good to use multivariate analysis, but I think the res are suspect. The raw data not in the paper, but if they that there were 27 IC injuri out of 314 (321 less 7 with CT), and that 13 of these h no skull fracture, then only of the 50 skull fractures we associated with IC injury. T gives a univariate odds rat 7.51 (not 21.5). Although th is still significant, it makes wonder about the veracity all the other results, as this the most significant result. Emphasis on odds ratios glosses over the fact that t PPV and NPV are arguably more important. Serious doubts about the analysis i this paper. Head injury full guideline, appendix 6; second consultation 39