Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
---|---|---|---|---|---|
Dietrich et al 1993 USA | n=322 <20y Head trauma All CT scanned | Single centre prospective cohort study. | Intracranial injury (ICI) if Glasgow Coma Score (GCS) = 15 | 11/195 (5%) All had one of: LOC, amnesia for the event, vomiting, headache, seizures, altered mental status, focal neurological deficit Loss of consciousness (LOC), amnesia, GCS<15, and neurologic deficit were significant for ICI. | All patients had CT scans but no clear criteria for scan. No data on neurosurgical (NS) interventions in minor Head Injury (HI). |
Quayle et al. 1997 USA | n=321 <18y Blunt, non-trivial HI | Single centre prospective cohort study. | ICI if normal neurology (normal mental status, no focal findings) | 16/266 (6%) All had headache or vomiting. 5 had NS intervention. Independent predictors of ICI = altered mental status, focal deficit, signs of a base of skull (BOS) fracture, seizure. Those <1 year may have ICI with few signs/symptoms. | Trivial HI excluded. Only 27 ICIs. 89 missed eligible children had lower admission rate. |
Wang et al. 2000 USA | n=157 <15y Blunt HI Paramedic-assessed GCS 13-14 | Multi-centre prospective cohort study | ICI if normal neurology (normal mental status, no focal findings) | 30/157 (19%). 5 (3%) had haematoma evacuation. | 52 eligible children not included. No data on other potential predictors of ICI e.g. focal neurology. Small number of ICI. |
Rate of SF or ICI if GCS=13 vs. rate of same if GCS=14 | No significant difference | ||||
Correlation of ICI incidence with changing GCS | 60% of patients with ICI had improving GCS in transit or ED. | ||||
Rate of LOC in ICI | No LOC in 67% with ICI. | ||||
Greenes and Schutzman 2001 USA | n=422 <2y Asymptomatic with no sign depressed/BOS fracture | Single centre prospective cohort study. Derivation of score based clinical decision rule (CDR) to predict SF (score based on age, haematoma size/location). | ICI rate | 13/422 (3%), 1 haematoma evacuation. All had SF. | CDR to predict SF only. Reliance on skull x-ray to stratify ICI risk. Subjective measure of haematoma size. |
ICI with scalp haematoma | 12/46 with scalp haematoma had ICI. | ||||
Missed ICI | No missed ICI at 2 week follow-up (F/U) on discharged patients. | ||||
CDR performance in predicting SF | Sensitivity (sens) 0.98, specificity (spec) 0.49. | ||||
Impact of CDR implementation | CT rate 35%. No ICI missed. | ||||
Murgio et al. 2001 Argentina, Brazil, France, Hong Kong & Spain | n=4690 <16y with HI n=3710 GCS 14-15 | Multinational prospective observational study | CT abnormality (fracture, ICI). | GCS 14-15: 55/3,710 (1.5% of total, 19% of those scanned). Propensity for abnormal scan if 3-9y. All GCS: 236/2690 (5.6% of total, 35% of those scanned). | Not restricted to minor trauma. CT indications unclear. No differentiation between ICI & fracture. |
Palchak et al. 2003 USA | n=2043 <18y Blunt, non-trivial HI | Single centre prospective observational cohort study. Derivation of CDR. Individual decision trees given for specific outcomes | CDR performance: ICI on CT or requiring intervention | Sens 99%, Spec 25.8%, Negative Predictive Value (NPV) 99.7%, Positive Predictive Value (PPV) 10% | Not restricted to minor HI. Discretionary CT (not all cases of LOC/amnesia). Record of LOC unreliable in many cases. Younger children unable to describe headache, LOC or amnesia. Incomplete F/U (but no missed ICI found). |
Performance of 4-point tree: Intervention (Neurosurgical (NS) procedure, antiepileptic drugs >1 week, persistent neurologic deficits, or hospitalization ≥ 2 nights) | Sens 100%, Spec 42.7%, NPV 100%, PPV 8.6% | ||||
Performance of 4-point tree: ICI on CT if GCS 14-15 | Sens 94.9%, Spec 49.5%, NPV 99.6%, PPV 6.5% | ||||
Performance of 3-point tree: NS procedure | Sens 100%, Spec 64.3%, NPV 100%, PPV 3.9% | ||||
Performance of 2-point tree: ICI on CT <2y | Sens 100%, Spec 33.5%, NPV 100%, PPV 11.2% | ||||
Palchak et al. 2004 USA | n=2043 <18y Blunt, non-trivial HI See (Palchak et al. 2003) | Single centre prospective observational cohort study. | ICI or intervention (see Palchak et al 2003 above) | 0% in those with isolated LOC (no vomiting, headache, fracture, seizure, mental alteration, neurology, scalp haematoma) | See (Palchak et al. 2003) |
ICI or intervention | 0% in those with isolated LOC and/or amnesia | ||||
Boran et al. 2006 Turkey | n=421 <17y Blunt HI, GCS 15, no focal neurology. All had XR and CT. | Single centre prospective cohort study | ICI | 37/421 (8.8%). 16 required neurosurgery. No significant association with headache, vomiting or scalp laceration. | Some SFs (BOS and depressed) classed as ICI. |
ICI if linear fracture on plain film | 11/38 (29%) | ||||
ICI if LOC | 14/23 (61%) | ||||
ICI if Seizure | 5/6 (83%) | ||||
New ICI at 24h. | Those with linear fracture had 2nd CT at 24h. 1 child with no ICI on initial CT had extradural haematoma at 24h. | ||||
Dunning et al. 2006 UK | n=22772 <16y with any head injury. | Multi-centre prospective cohort study. Derivation of CHALICE CDR. | CDR performance: ICI or depressed fracture if GCS 13-15 | Sens 97.6%, Spec 87.3%, PPV 5.44%, NPV 99.9%, CT rate 13.3%. | Selective CT (based on Royal College of Surgeons guidelines). No direct patient follow-up – selected information gathered from participating hospitals, local neurosurgical units and Office for National Statistics. No validation. |
Da Dalt et al. 2006 Italy | n=3806 <16y Blunt HI Analysed in 5 groups | Multi-centre prospective cohort study. CDR derivation. | ICI if A: GCS 15, no neurology, no clinical BOS or non-frontal fracture, asymptomatic | 0/2748 | Discretionary CT. Possible underestimated ICI rate. Difficult to separate those with minor HI. |
ICI if B: A + <30s LOC, impact seizure, non-prolonged vomiting or headache | 0/550 | ||||
ICI if C: A + >30s LOC, amnesia, drowsiness or prolonged headache | 3/233 | ||||
ICI if D: A + clinical non-frontal fracture. | 6/201 | ||||
ICI if E: abnormal GCS / neuro exam or clinical BOS fracture. | 13/66 | ||||
Accuracy of rule (A+B vs C+D+E) to predict ICI | Sens 100% Spec 87.3%, PPV 4.4%, NPV 100% | ||||
Oman et al. 2006 USA | n=1666 <19y Blunt HI who had CT | Multi-centre prospective cohort study. Derivation of NEXUS-II CDR, accuracy in paediatric subset. | CDR performance: Clinically important ICI (neurosurgical intervention [craniotomy, intracranial pressure {ICP} monitoring, or mechanical ventilation] or likely significant long-term neurologic impairment) | Sens 98.6%. NPV 99.1%. Spec 15.1%. 2 missed, one due to clinician error, neither required intervention. | CDR derived from mixed adult and child data. Only applied to those who had discretionary CT. Small group <3y. Not validated. |
Performance of CDR: Clinically important ICI in children <3y | Sens 100%, NPV 100%, spec 5.3%. | ||||
Atabaki et al. 2008 USA, Canada | n=1000 <21y Closed non-trivial HI, GCS 13-15 who had CT. | Multi-centre prospective observational study. Derivation of CDR. | Performance of CDR: ICI on CT | Sens 95.4%, Spec 48.9%, NPV 99.3%. 46.3% of sample would have avoided CT. Only 6 required NS intervention. | Discretionary CT. Small number of patients requiring intervention. |
Turedi et al. 2008 Turkey | n=240; 120 <16y, 120>16y. GCS 13-15, LOC<15min, Post-Traumatic Amnesia (PTA)<1h | Single centre prospective cohort study. High risk group (using criteria identified in meta-analysis (Dunning et al. 2004)) compared with low risk. | ICI on CT | Low-risk group: 7 ICI (4 <7y; 3 >6y), none needing intervention. High-risk group: 25 ICI (13 <7y; 12 >6y), undisclosed number intervention. 2nd scan in high-risk at 16-24h: 2 new ICI, no intervention. | Small sample. Paediatric data not analysed separately from adults. |
Kuppermann et al. 2009 North America | n=42412 <18y GCS 14-15, non-trivial HI. Derivation and validation populations: 8502 and 2216 aged <2y, and 25 283 and 6411 aged ≥2y <18y | Multicentre prospective cohort study. Derivation and validation CDR. | CDR performance accuracy <2y in terms of clinically important Traumatic Brain Injury (ciTBI) (death, neurosurgery, intubation >24 h, admission ≥2 nights) | Derivation: NPV 99.9%, sens 98.6%, spec 53.7% Validation: NPV 100%, sens 100% , spec 53.7% | Discretionary CT. Selected population Internal validation only. |
CDR performance accuracy ≥2y: cTBI | Derivation: NPV 99.95%, sens 96.7%, spec 58.5% Validation: NPV 99.95%, sens 96.8%, spec 59.8% | ||||
Osmond et al. 2010 Canada | n=3866 <16y Blunt minor HI | Multi-centre prospective cohort study. Derivation of CATCH CDR. | CDR performance: High risk criteria in terms of NS intervention | Sens 100%, Spec 70.2%, CT rate 30.2%. | Discretionary CT. Relatively few <2y. No validation |
CDR performance: High or medium risk criteria in terms of TBI on CT | Sens 98.1%, spec 50.1%, CT rate 51.9% for specific population included in derivation study. | ||||
Bin, Schutzman, and Greenes 2010 USA | n=417 <2y Blunt HI 203 with CT or X-ray. 214 with no imaging not included in validation set. | Single centre prospective observational study. Validation of previously derived CDR (Greenes and Schutzman 2001) | CDR performance accuracy: Score ≥4 & SF | All patients: sens 0.9, spec 0.78 Asymptomatic: sens 0.93, spec 0.68 | Almost 30% eligible patients not enrolled and this group much less likely to get skull XR. Discretionary imaging - CT or XR not evaluated separately. Qualitative estimate of haematoma size. 78% F/U (phone call at 1 & 4w) – possible missed ICI. |
CDR performance accuracy: Score ≥4 & ICI | All patients: sens 0.62, spec 0.64. Asymptomatic: sens 0.56, spec 0.59 | ||||
CDR performance accuracy: Score ≥3 & ICI | All patients: sens 0.93, spec 0.42. Asymptomatic: sens 1, spec 0.33 | ||||
Nigrovic et al. 2011 North America | n=40113 <18y GCS 14-15, non-trivial | Secondary analysis of PECARN subset – see (Kuppermann et al. 2009) above. | Impact of observation on rates of CT, clinically significant TBI, emergent NS intervention. | Significantly lower CT rate (31.1% vs 35%) if observed, no significant difference in ciTBI (0.75% vs 0.8%) or NS intervention rates (0.11% vs 0.14%). | No analysis of length of stay, length of observation or of significance of any delay to NS intervention. |
When was observation used? | Intermediate risk more likely to be observed than high or low risk. | ||||
Fabbri et al. 2011 Italy | n=2391 <11y Blunt HI | Retrospective validation of CDRs (Oman et al. 2006; Da Dalt et al. 2006) using single centre prospective cohort data. | Performance of NEXUS-II CDR in terms of any post-traumatic lesion on CT | Sens 88.9%, spec 59.4, NPV 99.9. | Discretionary CT. Not restricted to minor injury. Small no. of ICI (18) and NS intervention (2) |
Performance of Da Dalt CDR in terms of any post-traumatic lesion on CT | Sens 100%, spec 76.1, NPV 100 |