National Consultation on the Role of the
Laboratory Centre for Disease Control in
Policy and Guidelines: LCDC's Role in Support of TB Prevention and Control
The recommendations of the Policy and Guidelines group were discusssed at length in two plenary sessions. The Policy and Guidelines group report has been modified to include the recommendations of these plenary discussions.
The central issue addressed by the group was the necessity for a national TB program given that individual provinces and territories have their own established programs. The federal government is responsible for the provision of health services for the following population:
The Policy and Guidelines group recognized that for any national initiative to be successful, there is a need for multidimensional partnerships. These partnerships can be the basis for developing a national strategy to address TB prevention and control with the ultimate goal of eliminating TB in Canada.
The group identified the need to establish a national expert advisory group to set national strategies and priorities. The United States model based on the Advisory Council for the Elimination of Tuberculosis and the Canadian model based on the National Advisory Committee on Immunization (NACI) were discussed by the group. A group or committee consisting of scientific experts would be the most appropriate model for Canada to ensure credibility. This model must satisfy the need for coordination, establish good linkages between interested parties, maintain good communication, and develop national guidelines and policies for TB control in collaboration with other stakeholders.
The Expert Committee on Tuberculosis (ECOT) should be selected by LCDC and be composed of 9 to 10 technical experts (including epidemiology, TB control program personnel, laboratory, and research expertise). Its mandate is to advise LCDC on priority issues that must be addressed for the prevention and control of TB in Canada.
Members of the ECOT should be appointed for three years with a mechanism to renew the membership periodically. The composition of the ECOT was debated extensively. The principal concern was the need to guarantee representation by provincial and territorial TB authorities who are responsible for programs.
A proposal to create a standing subcommittee of the ECOT, consisting of provincial and territorial TB authorities and MSB, LCDC, and Statistics Canada representatives was discussed and accepted in the plenary sessions. This subcommittee would be supported by LCDC and it was agreed that the chairperson of this standing TB subcommittee would occupy a designated seat on the ECOT. Recommendations made by the ECOT would be shared with this subcommittee prior to release to ensure that TB program directors are able to comment on the impact of such recommendations on program operations.
To ensure the success of the ECOT and broaden involvement and participation by stakeholders, the critical principles governing the operation of the ECOT and LCDC's response to committee recommendations include effective, two-way consultation with all interested parties; the identification of a clearly defined pathway for communication with stakeholders; and the use of expert subcommittees to respond to specific questions. The performance of the ECOT should be evaluated periodically.
There was general agreement regarding the need for an inventory/review of current TB prevention and control activities/efforts in Canada to provide information for the development of a national strategy for TB prevention and control. The inventory/review process should be accomplished exclusively with national experts and resources and initiated and completed within the first year of operation of the ECOT. The Policy and Guidelines group decided there may be merit in seeking international commentary on the report produced by this process.
With respect to the need for a National Consensus Conference on Tuberculosis, the group felt that this was a topic to be referred to the ECOT.
The Policy and Guidelines group discussed the application of LCDC's mission, mandate, goals, and objectives in the area of TB prevention and control. The group felt that most of LCDC's goals and objectives apply to TB to a greater or lesser extent. Surveillance, maintenance of laboratory standards, and support for an expert committee on TB were identified as key areas for LCDC activity.
The group discussed the possible courses of action by LCDC in response to the draft document, "The Elimination of Tuberculosis in Canada: Report of the Committee on Tuberculosis Elimination, September 1, 1993". It was agreed that the document be referred to the ECOT as one of the first priorities to develop a national strategy for TB prevention and control in Canada.
RECOMMENDATIONS:
1. THAT a standing expert committee on TB (ECOT) consisting of 9 to
10 experts in the field of TB be convened by LCDC to recommend to
LCDC on policies, procedures and guidelines for TB control and
prevention in Canada.
2. THAT the ECOT should be composed of persons with specific expertise and skills. Possible areas of expertise include the following areas:
4. THAT the ECOT in consultation with LCDC develop terms of reference to govern its functioning. The ECOT should act as a steering committee to examine the broad strategic issues and organize ad hoc technical or working groups to address specific issues or areas.
5. THAT the ECOT include in its terms of reference the development of priorities for research in TB.
6. THAT the critical principles governing the operation of the ECOT and LCDC's response to ECOT recommendations include effective, two-way consultation; the identification of a clearly defined pathway for communication; and the use of expert subcommittees to respond to specific questions.
7. THAT LCDC provide support for the effective functioning of ECOT and ensure dissemination of the recommendations of the ECOT.
8. THAT the first priority of ECOT should be to develop a national strategy for TB prevention and control in Canada.
9. THAT the ECOT, as one of its early activities, undertake a national inventory/review exercise to provide baseline information on the current status of TB prevention and control in Canada for the development of a national strategy for TB prevention and control.
10. THAT LCDC refer the document, "The Elimination of Tuberculosis in Canada: Report of the Committee on Tuberculosis Elimination, September 1, 1993", to ECOT for further consideration and response.
11. THAT a TB subcommittee composed of provincial and territorial TB program authorities be sponsored by LCDC to consult with the Advisory Committee.
12. THAT one seat on ECOT be set aside for the chairperson of the standing TB subcommittee.
13. THAT a national consensus conference not be convened by LCDC at the present time.
SURVEILLANCE: Case-finding
TB surveillance is the collection, analysis, interpretation, and timely dissemination of data to those who will use this information for program planning and evaluation.
Most TB surveillance in Canada is based on the passive reporting of persons who seek medical care because of symptoms. The active search for TB cases in high risk groups might permit earlier identification of ill persons and should be evaluated.
TB case-finding was defined by the Surveillance Case-finding group as the identification of active cases in an organized and systematic manner, using available diagnostic tools (sputum microscopy and culture, Mantoux testing, x-ray) and newer technologies, for the primary purpose of minimizing transmission to other susceptible persons. Information collected during case- finding should be linked to treatment or case-holding information.
RECOMMENDATIONS:
14. THAT Statistics Canada should continue to receive and analyze
TB data from all Canadian jurisdictions and produce annual routine
reports.
15. THAT LCDC should work collaboratively with Statistics Canada and provinces/territories and other stakeholders to evaluate, standardize, and enhance the surveillance system.
16. THAT LCDC work collaboratively with Statistics Canada and provinces/territories and other stakeholders to enhance the national surveillance system and/or activities by:
17. THAT LCDC work collaboratively with Statistics Canada and provinces/territories, and other stakeholders to evaluate the components of provincial and territorial passive surveillance systems and activities including, but not limited to completeness, accuracy, and timeliness of reporting, and frequency and timeliness of dissemination of surveillance reports.
18. THAT LCDC evaluate the following components of provincial/territorial active surveillance (case-finding) systems and activities with special reference to cost effectiveness:
Surveillance: Case-Holding
Case-holding was defined to reflect the definitions provided in the "The Elimination of Tuberculosis in Canada: Report of the Committee on Tuberculosis Elimination, September 1, 1993", and "Proceedings of the National Workshop on Tuberculosis, HIV and other Emerging Issues" (May 3-5, 1993). Therefore, case-holding was defined as:
The Surveillance Case-holding group established that the following parameters should be collected on each TB case in order to permit case-holding surveillance:
The Surveillance Case-holding group felt strongly that there is a need for national data on TB treatment and outcomes to:
20. THAT LCDC, in coordination with other stakeholders, sponsor and participate in an evaluation of the current case-holding data to assess the availability and quality of such data and to assess the feasibility of acquiring the data necessary to meet the outlined objectives of case-holding surveillance;
21. THAT LCDC sponsor and participate in a technical working group regarding national case-holding surveillance if recommended by ECOT;
22. THAT LCDC with respect to the national case-holding surveillance data, participate in, coordinate, and conduct:
HIV/TB Surveillance and Research
TB has been recognized as an important pathogen in HIV- infected people for many years, but the dire implications for the co-infected person have not been thoroughly appreciated until recent years. In Canada, TB deaths are uncommon and mainly confined to the elderly. However, co-infected persons are more likely to have reactivation of latent TB, and they may have more rapid progression of TB disease.
In the United States, there have been outbreaks, with devastating consequences, of TB in HIV health care settings. Infections and deaths due to TB among HIV-infected patients and their care givers have been reported. Even care givers who were not HIV infected have become infected with TB. In some of these outbreaks, the tubercule bacillus has been resistant to drugs used for the treatment of TB, that is, MDR TB. Outbreaks of MDR TB in HIV-infected people have led to the transmission of MDR TB among non-HIV-infected people.
Canada is a country with a mix of populations from a variety of ethnocultural backgrounds, and with a large influx of immigrant populations from parts of the world where both HIV and TB are more common. As a consequence, the likelihood of co-infection among the Canadian population is growing.
The following paragraphs contain certain principles of importance and recommendations for monitoring the epidemic of HIV/TB in Canada, as discussed by the HIV/TB Surveillance and Research group. Among the most important principles is the need to ensure that collection of information about HIV status be conducted in such a manner that the confidentiality and privacy of HIV-infected persons is maintained.
i. Surveillance Systems for
HIV/TB
In Canada, there are routine sources of surveillance data for HIV,
AIDS and TB. AIDS data are routinely collected through ACRSS.
HIV-related information is collected mainly through investigations
and surveys utilizing a variety of epidemiologic techniques.
Statistics Canada routinely collects data on TB through the
TB-surveillance system. For both the TB and AIDS surveillance
systems, data are collected from clinicians, provided to provincial
and territorial sources, and then forwarded voluntarily to either
Statistics Canada (TB) or LCDC (AIDS). Collection of national data
on TB and HIV in Canada is clearly a cooperative effort requiring
the commitment and collaboration of each of the provincial and
territorial directors with LCDC and Statistics Canada in a true
partnership.
In order for us to understand the epidemiology of co-infection with TB and HIV, data collection on co-infection with TB and HIV must be performed. Collection of these data is essential to provide information for decision making to governments, policy makers, and the HIV infected population. Their inclusion in the development and use of TB/HIV data will be essential.
Recognition of the importance of the collection of epidemiologic information about co-infection with HIV and TB must respect the privacy and confidentiality of persons with co-infection. Testing for HIV must be voluntary, confidential, and performed in an environment that includes pre-test and post- test counselling.
We must develop a commitment to partnership in the development of an HIV/TB co-infection data system and partnership in the use of data from the system. The partnership should include the following persons/institutions:
The goal of the co-infection surveillance system is to collect, analyze, and disseminate information about the epidemiology of co-infection with HIV and TB for the purposes of limiting new infections and improving the care of persons with co-infection. To accomplish this goal, we need to develop a national non-nominal data base on co-infection with TB and HIV. It should not be necessary to create an entirely new surveillance system, since there are two well-established, secure and respected national surveillance systems already in place that collect information about either AIDS or TB. Instead, our recommendations regarding the principles for the surveillance system are as follows:
Based on existing function and LCDC's national role in the collection and collation of HIV information, the HIV/TB co-infection data should be collected and collated by LCDC, in cooperation with provincial and territorial partners, laboratory partners and Statistics Canada.
ii. Intervention Research
The development of surveillance systems will aid policy makers and
public health officers by creating a source of data to support the
allocation of resources to the prevention and management of
co-infection of HIV and TB. However, there is a need to also
develop a body of information about the efficacy and effectiveness
of interventions. In addition, research about intervention
strategies is required to ensure the adoption and appropriate use
of efficacious interventions.
The HIV/TB Surveillance and Research group recommended the development of epidemiologic investigations in this area. Possible supplementary studies include the following:
iii. Outbreak Investigations and
Management
The detection, investigation, and control of outbreaks of TB among
HIV-infected populations is an essential activity, central to TB
control in Canada. The rapid deployment of resources to investigate
and manage outbreaks of co-infection will be key to the prevention
of transmission of TB.
There is a need to develop a better understanding of the epidemiology and co-infection and the transmission of TB among HIV infected persons. As a consequence, there is a requirement for a commitment of resources to this activity. The resources that are essential include the following:
iv. Dissemination of Reports
The rapid dissemination of accurate data about co-infection with
HIV and TB is key to the development of useful epidemiologic
surveillance systems. To this end, LCDC should ensure that reports
are written and disseminated.
v. Ensuring the Rapid Development of
Epidemiologic Information
The epidemiologic nature of co-infection with HIV and TB has a
dynamic independent from the dynamic of endemic TB and epidemic
HIV. Because of this, there is a need for immediate action.
Consequently, HIV/TB epidemiologic investigations should be
regarded as a priority area. Clearly, the investigations will be
conducted in tandem with investigations of HIV and TB already
ongoing in Canada, and will become a part of the national HIV
control- as well as national TB-control programs. However, the
development of the work plans must not be delayed.
LCDC should immediately appoint a working group to advise the Division of HIV/AIDS regarding co-infection with TB/HIV. This committee should consist of the persons already involved through the "National Conference on LCDC's Role in TB in Canada" and other volunteers as seems necessary. This group should collaborate with the Division of HIV/AIDS in the development of a work plan for this year (fiscal year ending March, 1995) and development of work plans for 1995/96. An important role for this group will be the development of information material and its dissemination. Communication will be by teleconference, initially, and the group will meet as quickly as possible. (Additional persons to add to the group might include representatives of the laboratories, Statistics Canada, provincial TB coordinators, provincial AIDS coordinators, community-based AIDS workers, and Immigration Canada; the information network may require inviting of guests and other mechanisms for consultation.)
RECOMMENDATIONS:
23. THAT LCDC create a national data set of appropriate
epidemiologic information about co-infection with TB and HIV.
24. THAT LCDC liaise with Statistics Canada for the collection of TB data and continue to receive and analyze HIV data from all Canadian jurisdictions.
25. THAT LCDC revise HIV- and AIDS-surveillance reporting forms to capture HIV/TB data, wherever possible and appropriate.
26. THAT LCDC should consult on the feasibility of including in TB-surveillance report forms voluntary, confidential information on HIV. Collection of risk-factor information for HIV may be used as a surrogate for HIV information on TB surveillance forms.
27. THAT LCDC should coordinate and collaborate in special investigations to determine the extent of HIV infection among people with TB infection and TB disease.
28. THAT LCDC participate in intervention research about the management of co-infection, particularly in the area of chemoprophylaxis usage and completion of therapy. The use of methods such as sentinel clinical sites and third party record linkage should be explored.
29. THAT LCDC encourage HIV testing in TB clinical settings. Conversely, tuberculin skin testing should be encouraged in HIV clinical settings.
30. THAT LCDC should coordinate and collaborate in supplementary epidemiologic investigations including studies of sentinel sites to examine the barriers to surveillance; barriers to chemoprophylaxis; and barriers to implementation of prevention programs.
31. THAT LCDC, in collaboration with provincial, territorial, laboratory, and community-based partners, create a standard outbreak investigation format for TB/HIV.
32. THAT LCDC, in collaboration with provincial, territorial, laboratory, and community-based partners, participate in cluster and outbreak investigations of co-infection with TB and HIV. Participation should include the provision of expertise, resources, and staff.
33. THAT LCDC should ensure the timely dissemination of information about TB/HIV co-infection, using collaborative models that are participatory in nature.
34. THAT LCDC create an advisory group to LCDC regarding HIV/TB, which should meet as soon as possible in order to coordinate collaborative investigation of the epidemiology of co-infection with TB/HIV. This advisory committee will act in an ad hoc manner until the resolution of the overall strategy for TB control in Canada.
Reference Laboratory Services and Research
There is a need for a national TB laboratory network. This Network must consist of a loose aggregation of LCDC and provincial laboratories. The resources needed to support a national TB laboratory network must be identified.
LCDC's National Reference Centre for TB should coordinate the Network by establishing a communications framework and organizing annual meetings. The Network must provide timely results and be comprehensive to members, be non-exclusive in testing (i.e. allow methodology to be developed and used in more than one site), be reliable and current (state-of-the-art), free to members (not revenue-generating), and collaborative in nature. The responsibilities of LCDC's National Reference Centre for TB with respect to the Network include the following:
The need for periodic drug resistance surveys should be reviewed in conjunction with ECOT every three years.
Developments in technology threaten the availability of information on strains because private and hospital laboratories can now possess the ability to generate information from specimens without isolation of strains. Mechanisms to ensure the continual capture of information and quality assurance are not currently in place.
RECOMMENDATIONS
35. THAT LCDC form a national tuberculosis laboratory network.
36. THAT the national tuberculosis laboratory network should include LCDC and all provincial laboratories. Its mandate will be to operate in a collaborative fashion, using current methodologies, to be comprehensive, and to provide timely services. It is not intended to be exclusive in testing, and there will be no charge for members of the network.
37. THAT LCDC establish and maintain an inventory of resources and available services within the network.
38. That LCDC provide and coordinate services such as a full range of proficiency testing, quality control, and standardization required by the provinces.
39. THAT LCDC facilitate the transfer of technology where feasable, including training services.
40. THAT LCDC coordinate the provision of provincially required services such as reference identification and reference susceptibility testing. These services include MTB susceptibility testing to second-line agents; susceptibility testing of Mycobacterium avium complex; development of standardized methods for MOTT; TB DNA fingerprinting and other typing methods; sequence-based DNA speciation; and serum drug levels.
41. THAT LCDC coordinate the inventory and maintenance of a mycobacterial culture collection.
42. THAT LCDC coordinate the creation and management of a centralized national data base for M. tuberculosis. This data base should include drug resistance information, and should be developed in a form useful to epidemiologists (including those working in the domain of HIV/AIDS epidemiology) with openness to sharing of information, and consensus of participating provinces. The need for a national susceptibility survey should be reviewed by the Network periodically.
43. THAT LCDC continue to participate in international laboratory liaison/activities.
44. THAT LCDC explore research issues/priorities within the network.
45. THAT core services be maintained during and after the transfer of the National Laboratory to Winnipeg scheduled for 1996-1997.
General Recommendations
During the consultative process many suggestions germane to the
prevention and control of TB were raised but did not fit within the
domain of the specific working groups. These include the
following:
The epidemiology of TB is changing, with some jurisdictions reporting increases in reported TB cases. To address these situations many resources have been devoted to developing necessary information packages and/or programs for the general public, health care workers, and high-risk populations. The Surveillance Case-Finding working group discussed the need for a "clearing house" for these educational materials and suggested that a role for LCDC would be to ensure the creation and funding of a "clearing house" (e.g., housed at the national office of The Canadian Lung Association).
As well, LCDC should undertake the production of a quarterly newsletter of TB activities in different jurisdictions by different agencies. The production of the newsletter could be contracted out, and could be used to disseminate information about the status of various activities related to the enhanced federal TB-funding initiative, referred to as the Munli Year Operational Plan (MYOP). This newsletter should include information about educational materials and opportunities for field staff.
LCDC should assist all Canadian jurisdictions in the design and conduct of TB-program evaluations. This should include identification/development/dissemination of standards and prototypes for program evaluation.
One of the results of fiscal constraint has been the decrease in the surge capacity of the system, or the ability to address emergency situations necessitating an acute need for increased resources. In the event of a large (community, occupational, nosocomial) or more dangerous outbreak (MDR TB), the working group for the Reference Laboratory Services and Research recommended that Canada should have an emergency preparedness plan for TB.
RECOMMENDATIONS:
46. THAT LCDC ensure the creation and funding of a clearing house
for educational materials devloped for the prevention and control
of TB.
47. THAT LCDC ensure the production of a TB quarterly newsletter.
48. THAT LCDC assist jurisdictions in the design of TB program- evaluation methodology, including the identification, development,and dissemination of standards and prototypes for program evaluation.
49. THAT LCDC, in consultation with the ECOT on TB, consider the need for an emergency preparedness plan for TB.