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วันจันทร์, มีนาคม 29, 2547

Jay Mail

15 June 47

All,
I wanted to provide a brief update to everyone about a few important issues that were discussed at the 8 June 2004 TB Steering Committee Meeting.
(1) The committee believes that the MOPH ethical review committee does not need to review the surveillance protocol. Dr. Wonchat will discuss with the BMA whether any ethical review committee approval is needed in Bangkok.
(2) USAID will provide funding to CDC to work on TB/HIV in Southeast Asia. The first project in Thailand will involve a study of the high mortality rate among TB/HIV patients in Thailand. This project will be funded separately from the GAP cooperative agreements. A meeting to begin protocol development will be held on Wednesday, 30 June 2004, from 1:30 – 4 p.m. at TUC.
(3) Network sites should make sure that their 2004 Continuation Proposals (due this July!) include sufficient funds to conduct the “pre-surveillance assessment.” I do not think that new staff needs to be hired for this assessment, but you may want to request funds for office supplies and travel expenses to conduct this assessment. This “pre-surveillance assessment,” as discussed in the meeting, is an attempt to quantify the number of health care facilities that provide TB diagnostic or treatment services in each network site. A draft protocol with case definitions will be developed and circulated to the study team.
(4) The next TB steering committee meeting will be held on Monday, 30 August 2004, from 1:30 – 4 p.m at TUC.
(5) Dr. Yuttichai has been working with K. Daranee in our office to finalize the Thai translation of the protocol. I will circulate the Thai translation, minutes from our meeting, and other updated forms in a subsequent email.
Thank you,
Jay




@21 May 2004

21 May 2004 files attached:
1Agenda_v1.doc
2Population_Based_TB_Surveillance_Protocol_v_10.doc
3AQ_Population_Based_TB_Surveillance_Protocol_v_10.doc
4Core_Data_Elements_v6_Thai__formatted_for_Database.doc
5Core_Data_Elements_v6____Formatted_for_Database.doc
6Surveillance_Assessment.doc
7List_of_Diagnostic_Centers.xls
8Tan_protocol_GLC____abbreviated.doc

Dear Drs.:

Attached you will find the agenda for TB Steering Committee Meeting, scheduled for June 8, 2004, 13:30-16:30 on the 3rd floor, TUC Meeting Room for your views as well as documents for the meeting.

(1) Draft Agenda for 8 June 2004 committee meeting.
(2) English version of surveillance protocol
(3) Thai version of surveillance protocol
(4) English version of “Core Data Elements”
(5) Thai version of “Core Data Elements”
(6) Pre-surveillance assessment (Word file “Surveillance Assessment” + Excel file “List of Diagnostic Centers”
(7) Green Light Committee Proposal (Word file “Tan protocol GLC – abbreviated”)

The formal invitation letters will be sent to you in the very nearly future.

Regards,



Daranee Sareenun
Program Management Assistant
TB Prevention and Control Section
Thailand MOPH-U.S. CDC Collaboration
DDC 7 Building, MOPH, Nonthaburi 11000
Tel. 66-2-580-0669 ext.
Fax. 66-2-591-5443
Mobile: 01-621-8444
e-mail daranees@tuc.or.th


@Ealier May 47
File attached: Population_Based_TB_Surveillance_Protocol_v_10.doc
All,
(1) Great news from CDC! On 27 April 2004, our protocol was determined to be “non-research.” This means that no further review from CDC is required and no formal IRB protocol / review is required. Attached to this email is the most up-to-date version of the protocol.

(2) We hired a person to translate the final protocol into Thai. We have received the first draft of the translation, but we would like persons at TUC to review the Thai translation before sending to the group. If you would like to see the Thai translation before it is finalized, then please email me and I will send you this draft.
(3) Our next TB steering committee meeting is scheduled for Tuesday, 8 June from 1:30 – 4 p.m. at TUC. I will send a proposed agenda and further details soon.
Thank you,
Jay

@Subject:TB Net: Update on CDC Review, Thai Translations, Database
All, 26 March 47 with file Population Based TB Surveillance Protocol v 10.doc

(1) The protocol for active TB surveillance was submitted to CDC for non-research determination this week. I will keep you updated on the progress of this. We are hopeful that we will have an answer from CDC by the end of April.
(2) I have attached a copy of the most recent English-language version of the protocol and core data elements.
(3) I have attached a Thai translation of the core data elements. Please review this document and email K. Daranee Sareenun (Toi) (email: DaraneeS@tuc.or.th) or me if you have concerns about the translation.
(4) We have submitted the English-language protocol to a contractor for translation. We hope to receive a version back within 1-2 weeks, but it will be reviewed extensively by persons here in our office to make sure the translation is accurate. Once we have a TUC-reviewed Thai translation, I will circulate it to the group for final review.
(5) The IT group at TUC is working on developing a preliminary version of the electronic database. I will keep you updated on the process, because we will need all of your advice on how to make it satisfy your needs.
(6) I will be leaving for the United States this Saturday (27 March) and will return to Bangkok on 1 May. I will be checking email daily. If there are urgent issues, please telephone K. Daranee Sareenun (Toi) at TUC, and she can assist you.

Thank you for all of your hard work on developing this project. We are excited to see it moving forward.

Jay Varma, MD
Chief, TB Prevention and Control Section
Thailand MOPH – U.S. CDC Collaboration

@ Subject:TB Net Steering Committee: Meeting summary, preparation for GAP program review
18 March 47 with file Meeting_Summary____TB_Net_Committee_10_March_2004.doc
All,



(1) Attached to this document you will find a draft summary of our last TB steering committee meeting. Please review and send comments or corrections back to me. Since several discussions were held in Thai, I may not have captured all the important points from the last meeting.

(2) From 10 May through 21 May, staff from CDC/Atlanta will be visiting TUC to review our HIV/AIDS programs, including TB. K. Daranee Sareenun (Toi) will probably contact many of you on my behalf to prepare for this review. We will need to document what activities we have performed and to provide evidence about these activities (e.g. if a training course was held, we should have the agenda and training curriculum available). K. Daranee will work with all of you to collect this information. This is also a good opportunity to organize our documents so that they could be shared with each other.

(3) As discussed on 10 March, the next TB steering committee will be held on 8 June 2004, from 1:30 – 4 p.m. at TUC.

(4) I will keep all of you informed the status of CDC’s “non-research determination.” The documents are being reviewed here at TUC, and we hope to send to CDC by the end of next week.

Jay

@Subject:GAP TB Steering Committee: Updated "Core Data Elements"
11 February 47 with file Core_Data_Elements.doc

All,



I have received comments on the "Core Data Elements" from some of you. Some additional data elements have been added to the list and others have been slightly revised. Please revise this document as soon as possible and let me know whether you agree with these changes.



Specific additions include:
-Hospital ID number

-District TB registry number

-If no health care worker observer, was health care worker assigned to observe treatment 1 time per week in initial phase?

-Sputum conversion result

-Resistance pattern of sputum specimens (if known)

-Results of non-sputum specimens obtained


Thanks,
Jay

Subject: GAP TB Steering Committee: Update on 27 January Meeting



All,



(1) We had a wonderfully productive meeting on 27 January 2004 to discuss epidemiologic issues related to the TB surveillance project. Representatives from BMA, Chiang Rai, Ubon, Phuket, MOPH, RIT, and TUC were able to attend. It was a wonderful example of how this collaboration has moved forward. All participants provided input, allowing us to have lively, fun discussions. Some important outcomes included:

a. Revising the case definitions and protocol for surveillance;

b. Revising the information technology plan for managing the epidemiologic data;

c. Developing "core data elements" for each case ascertained in surveillance.

(2) A copy of the "core data elements" is attached to this email. It is presented in a table format to allow you to see the data we hope to collect. Each network site will develop its own data collection form, but each network's form(s) must record these core data elements.

a. Please review this form and send comments back to me as soon as possible.

b. When reviewing this form, keep in mind that this data is meant for surveillance. We realize that this may be too much data to collect from some facilities (e.g. private hospitals) or too little data to collect from NTP patients. We hope the data elements we agreed on represent a good balance between what is practical and what we need for surveillance, monitoring, and program improvement.

(3) I am currently updating the protocol based on comments received at the steering committee meeting, comments sent by email, and our 27 January meeting. I will send out a revised version before the next meeting.

(4) Information regarding the 10 March 2004 steering committee meeting will be mailed to you soon.

(5) As always, please email or telephone me if you have questions, concerns, or changes you would like to suggest.



Thank you,



Jay

@Thailand GAP TB Steering Committee: Committee meeting on March 10 , 2004
sent on 10 february 47 with file Agenda_v1.doc

All,



Attached you will find a draft agenda for the next TB steering committee meeting, scheduled for 10 March 2004 from 1:30 p.m. - 4 p.m. at TUC. Please let me know if you would like to add or remove items from this agenda. The primary objective for our next meeting will be to finalize the protocol and agree on a plan for IRB/ERC review and implementation.



Jay

@Subject:GAP TB Steering Committee: Update on 27 January Meeting
sent on 30 January 47 with file Core_Data_Elements.doc

All,



(1) We had a wonderfully productive meeting on 27 January 2004 to discuss epidemiologic issues related to the TB surveillance project. Representatives from BMA, Chiang Rai, Ubon, Phuket, MOPH, RIT, and TUC were able to attend. It was a wonderful example of how this collaboration has moved forward. All participants provided input, allowing us to have lively, fun discussions. Some important outcomes included:

a. Revising the case definitions and protocol for surveillance;

b. Revising the information technology plan for managing the epidemiologic data;

c. Developing "core data elements" for each case ascertained in surveillance.

(2) A copy of the "core data elements" is attached to this email. It is presented in a table format to allow you to see the data we hope to collect. Each network site will develop its own data collection form, but each network's form(s) must record these core data elements.

a. Please review this form and send comments back to me as soon as possible.

b. When reviewing this form, keep in mind that this data is meant for surveillance. We realize that this may be too much data to collect from some facilities (e.g. private hospitals) or too little data to collect from NTP patients. We hope the data elements we agreed on represent a good balance between what is practical and what we need for surveillance, monitoring, and program improvement.

(3) I am currently updating the protocol based on comments received at the steering committee meeting, comments sent by email, and our 27 January meeting. I will send out a revised version before the next meeting.

(4) Information regarding the 10 March 2004 steering committee meeting will be mailed to you soon.

(5) As always, please email or telephone me if you have questions, concerns, or changes you would like to suggest.



Thank you,


Jay

@Subject:Thailand TB/HIV guidelines
sent on 29 Jan. 47

@subject: GAP TB Steering Commitee: Upcoming Meetings
sent on 23 Jan. 47 with file Agenda_for_TB_Epi_Group_28_January_2004.doc
All,



Here are some updates on the 2 meetings we have scheduled for the TB active population-based surveillance.



(1) 28 January 2004, Epidemiology Sub-Committee Meeting, at TUC, 0830 - 1600

a. Invitation letters have been mailed to GAP TB steering committee representatives this week.

b. A draft agenda for this meeting is attached. The purpose of the meeting is to work on the details of the main epidemiology components of the protocol. These include the case definitions, protocol for conducting surveillance, and the model case report form(s) (e.g. core data elements to collect).

c. Because this is meant to be a day for work on very specific details, I have asked to keep the group small. We are asking each network (BMA, Chiang Rai, Ubon, Phuket) to send one representative to the meeting. We have also asked for representatives from RIT, the Bureau of AIDS, TB, STIs, and the Bureau of Epidemiology. If other persons would like to attend (e.g. consultants), please let me know.

d. After this sub-committee has completed its work, I will email the results to the group.



(2) 10 March 2004, GAP TB Steering Committee, at TUC, 13:30 - 16:30

a. This date has been confirmed by Dr. Daranee. We will send out invitation letters and a proposed agenda soon.

b. The purpose of this meeting will be:

i. To review the revised protocol, including the work performed by the sub-committee on 28 January 2004

ii. To set up a schedule for submission of the protocol to ethical review committees / IRBs

iii. To set up a schedule for further development of the surveillance system, including laboratory, information technology, human resources, and training.



Thanks,



Jay Varma, MD
Chief, TB Prevention and Control Section

Thailand MOPH - U.S. CDC Collaboration


@subject: GAP TB Steering Committee: Sample forms for 28 January Epidemiolo gy Meeting
sent on 16 Jan 47 with file
1.Case_Report_Form_4.doc
2.Case_Report_Form_1.doc
3.Case_Report_Form_2.doc
4.Case_Report_Form_3.doc

All,



As discussed on 14 January, we will hold a meeting on 28 January to discuss the major epidemiology components of the proposal: specifically, case definitions, a protocol for ascertaining cases, and data collection forms / database.



To speed that discussion along, I have prepared some draft forms for you to review. Some issues about these forms:

(1) I prepared these based on a review of the forms used by the Bureau of Epi, National TB Reference Laboratory Center, NTP patient care/DOTS, BMA, and Ubon. I also included information that I thought would be important to collect.

(2) There are 4 separate draft forms. I created 4 separate forms so that I could separate the information into a logical order. Here is a brief review of these:

a. Form 1 = information to be collected when TB patient is first identified

b. Form 2 = information to be collected after patient completes treatment (or defaults, transfers, or dies)

c. Form 3 = laboratory information for a specific case

d. Form 4 = information about HIV testing / results. Needs to be separate so that data can be kept anonymous.

(3) If your site uses a data collection form different from the MOPH or BMA forms, please email this form to the group as well. I think it will help to review what information should and should not be collected before we meet on 28 January.

(4) Your network site may want to use its own unique form, and only use a common surveillance system database to link the data from the networks. That said, I think we should still develop and agree on sample paper forms first. We can use these sample forms to construct the database. This will make it easier to communicate our information to others and will make it easier for sites which do not have their own form to join the system.

(5) I realize that we may need to make these forms shorter or change their format. If possible, please email me comments before 28 January. This will help me speed up our discussion on 28 January.



Thanks,



Jay





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