Q. How do I join the study as a local collaborator?
A. Please contact Agam Jung( Principal Investigator) via e mail. She will add your name as a local collaborator (minor amendment to the ethics application). You will then need to submit a site specific form to your local CLRN. The hospital R&D department will help you in this process. You will need to be registered with IRAS (https://www.myresearchproject.org.uk/signin.aspx)
Q. Has the study obtained Ethics approval?
A. The study has been approved by the North Wales Research Ethics Committee (REC Reference Number - 10/WNo01/44, Protocol number UoL000613; version 17 dated 18/07/2010), Anendment number 43922/139881/13/504/3568/185353 NOSA AM01, 02 August 2010
Q. Do I have any access to NHS Service Support Costs?
A. The study has been accepted on the NIHR portfolio and can be viewed on the Portfolio Database at http://public.ukcrn.org.uk/search/).
This will ensure that your site will have access to NHS service support costs.
Q. Has the study been accepted by the NIHR portfolio?
A. The study has been registered on the NIHR CSP (Electronic submission to NIHR Coordinated System: 43922/134155/14/954). It has been validated by the Cheshire and Merseyside UKCRN.
Q. Can I include patients with a Tuberculoma in the study?
A.If your patient had a CSF study done for suspected TB meningitis then he /she can be included in the study. If you did not do a lumbar puncture (due to any reason e.g. contraindication on neuroimaging) then the patient has to be excluded from the study.
Q. The Medical Records department at my Trust wants to know which codes they have to use to identify any patients with TB meningitis. Can you please let me know the diagnostic codes?
A. The ICD-10 classification is used by medical records departments in the NHS http://apps.who.int/classifications/apps/icd/icd10online/
Most patients are coded under Tuberculosis (A 15-19, A 17+) or under the Diseases of the Nervous System ( G00-G99).Common codes that are used are A178, A171,A170,G01*,G07*,G998)
Q. What is the HPA Identifier number? I have/ have not been provided with this number by the HPA.
A. The HPA will send you a list of patients with a diagnosis of TB meningitis (cases). Each patient on this list will have an HPA Identifier number which you need to enter on the e-CRF. None of the controls will have an HPA identifier number as they will have been identified by you through your own TB database and microbiology records.
Q. How do I annonymise the patients for data transfer?
A. Region codes are given alphabets A-J .
Each hospital has a unique number starting from 01 - 50.
Each site will start patient coding as 001, 002 ....
For example, the first patient entered from Kings College Denmark Hill, will be coded as C/02/001 and the second patient would be C/02/002.
The coding document is available on the home page (left hand navigation bar). Please ensure that the patient number is entered on the Quality of Life questionnaire which is mailed out to the patient.
Q. We think that some of our TBM notifications may have been diagnosed abroad and then notified on return to this country. Does that matter?
A. We aim to recruit as many patients who were diagnosed to have TB meningitis between the dates 1/1/2006 - 31/06/2010. If your patient was diagnosed between these dates and you have cared for him/her please enroll him in the study, provided he/ she fulfills the inclusion criteria. If you do not have access to the CSF results which led to the diagnosis of TBM, the patient will have to be excluded from the study.
Q. We have some patients who have not been reported to the HPA. Can we include them in the study?
A. Yes, you can include any patients with suspected TB meningitis between the dates 01/01/2006 and 31/ 06/ 2010 irrespective of the fact whether they were reported to the HPA or not.
Q. Which are the TB endemic areas?
A. The WHO/HPA define TB endemic countries as those countries where the annual incidence of TB exceeds 40/100,000 population per year. Please access the following links to see the TB endemic areas.
Q. Is there a Site specific Activity Record which I need to keep?
A. It is recommended that you keep track of your research activity on the downloadable Excel sheet ( Home page, Left Navigation Bar). This should be saved on a password protected NHS computer; inline with the Data Protection Act. This Excel sheet is for your use and benefit and should not be transferred to the Central Site at Liverpool.