The CARE-HEAD JOLT Study Head Jolt in Suspected Meningitis
a multinational e-mail/web-based study
Copyright ©2001-2002, CARE-HEAD JOLT
* Completed April 2003 *

Acute meningitis is a serious disorder and carries a significant morbidity and mortality, particularly if untreated. Ruling out meningitis often requires lumbar puncture to assess the CSF. This is an invasive procedure and not without its own risks. To avoid unnecessary invasive procedures, it would be useful to be able to identify clinical features that could distinguish patients at high and low risk of meningitis.

A recent systematic review of this topic was published as part of the Rational Clinical Examination Series.^[1] 10 studies (1 was a prospective study) were included in the review. Since most studies were retrospective, little data was available on specificity. Individual items of the clinical history had low accuracy for the diagnosis of meningitis in adults. On physical examination, the absence of fever, neck stiffness and altered mental status eliminated meningitis (sensitivity 99-100% for the presence of 1 of these findings). Only 1 study has assessed Kernig's sign and only the original study has evaluated Brudzinski's sign. In a prospective study ( n=54), the head jolt manoeuvre was found to have a sensitivity of 97% and a specificity of 60% for meningitis.^[2]

1. JAMA 1999;282:175-81.
2. Headache 1991;31:167-71.

In patients suspected of acute meningitis what is the accuracy of the clinical history and head jolt manoeuvre, Kernig's sign, Brudzinski's sign and neck stiffness for the diagnosis of acute meningitis?

What is the precision of each of these signs?

• Investigators will be invited to join using the Internet
• Investigators can be from primary, secondary or tertiary care settings
• The Internet will be used to enrol in the study and to complete data collection
• Each investigator group will have responsibility for obtaining local ethics approval and proof of this must be forwarded to the study-co-ordinating centre on request
• The investigator completing the clinical examination must be blind to the results of the lumbar puncture and therefore the testing of the CSF must be performed by a second, independent investigator
• Each investigator should enrol at least 6 patients
• If possible, a second investigator will repeat the clinical examination (blind to the results of the first assessment and the results of the LP) within 15 minutes of the initial assessment
• Clinical exam must be done before the LP.
• The 2 investigators performing the clinical exam should be the same throughout the study period.

Patients will be of 2 sorts:

1. Consecutive, eligible patients without lateralising signs, with GCS 15, who are undergoing lumbar puncture because of suspected meningitis
2. Consecutive patients undergoing lumbar puncture for any reason

Exclusions:

• Patients < 18 years of age
• Patients who are comatose
• Patients unable to give consent

Resuscitation, antibiotic treatment (and imaging) should come first as deemed necessary by the responsible physician. Resuscitation that is needed should not preclude the patient from subsequent inclusion in the study provided that no more than 4 hours elapses between treatment and LP.

The examination must be performed prior to and within 4 hours of the LP and the investigator performing the clinical examination must be blind to the results of the LP. The presence/absence of the following signs and symptoms will be noted:

• History:
  • headache
  • fever
  • photophobia
  • rash (purpuric, petechial or ecchymotic)
  • nausea
  • vomiting
  • altered mental status (note: if patients are confused, they will not be able to participate because they will not be able to give consent)
• Physical:
  • Kernig's - positive, negative or equivocal Considered positive if passive extension of the knee (after flexing the hip 90 degrees) with the patient in a supine position, elicits resistance or pain in the lower back or posterior thigh
  • Brudzinski's - positive, negative or equivocal Considered positive if passive flexion of the neck in a supine patient causes spontaneous flexion of the hips and knees
  • Neck Stiffness - positive, negative or equivocal Considered positive if, while in a supine position, the patient resists passive flexion of the neck (so that the shoulders are lifted if the occiput is raised)
  • Head Jolt - positive, negative or equivocal Considered positive if patient's headache is increased when the patient turns his or her head horizontally at a frequency of 2-3 times per second
  • Fever
  • Rash

When possible, a second, independent investigator (blind to the results of the LP and the first clinical assessment) will perform the clinical examination on the same patient within 15 minutes of the first assessment.

Any of the following:

• CSF with elevated WBC >= 5mm³. If bloody tap correct WBC: (blood WBC x CSF RBC)/blood RBC
• Pathogens cultured from CSF
• PCR confirmation using CSF

Final Clinical Diagnosis will also be recorded

For investigators who haven't registered for HEADJOLT yet:

1. Register for the study using the online form at http://www.CAREStudy.com/HEADJOLT/Registration.asp (or click on 'HEAD JOLT' and 'Go' in the Data Entry drop down box on the CARE home page. This takes you to a login page and prompts you to click if you haven't registered as an investigator yet.)
2. Once you have completed and submitted this registration form, you will be issued with an Investigator ID and asked to supply a password for subsequent data entry.
3. Once we confirm your information, we'll add you to the lists of both CARE members and HEAD JOLT investigators.
4. Once you submit your password, you will be welcomed to HEAD JOLT. To enter data on a patient, click on 'HEAD JOLT' and 'Go' in the Data Entry drop down box.
5. Enter your patient's ID number and complete the data entry form. Investigators should use their own system of numbering patients. You'll notice at the top of the page there will be a list of any patient ID numbers that you have already used.
6. Once you have entered all data, click "submit". The data will then be reformatted and you will be asked to check the data you entered. If you have made any errors in data entry, you can make them on the previous page. If you want to revise any data, click 'No' at the bottom of the screen in response to the Submit query. Once you are satisfied with your data, click 'Submit'. If you have used a patient ID number which you have used previously, you will be asked to assign a new patient ID number and to resubmit the data. If you leave any information incomplete, the data won't be accepted and you will be prompted to supply the missing data. If after completing this process, you recognise an error has been made in data entry, contact us at carestudy@rogers.com
7. To enter data on another patient, click 'HEAD JOLT' and 'GO' in the Data Entry drop down box.

For investigators who have already registered and received an ID number and password:

1. Go to the login page at http://www.CAREStudy.com/HEADJOLT/login.asp and enter your ID number and password.
2. Follow steps 5 to 7 above.

Data collection forms can be downloaded as an Adobe PDF file by clicking here.

Sensitivity, specificity and LRs for each of the clinical exam manoeuvres will be calculated using the results of the LP as the reference standard. The kappa for each of the manoeuvres will also be calculated.

A multivariate analysis will also be done to attempt to identify a useful, multivariate diagnostic model.

Enrolment to continue for at least 1 year.

• First analyses and drafts will be sent to participating investigators
• After the investigators are satisfied with the ms and the analysis, it will be submitted to a journal by mutual agreement with the authors and will include a line stating "on behalf of the CARE-HEAD JOLT study group"
• All investigators and methodologist will be included and will be listed in descending order by the number of patients they enrol

Proposed by Richard Hardern of Leeds, England.

* Any comments or concerns about this protocol, please email carestudy@rogers.com.