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Canadian Tuberculosis Standards - 8th Edition

Preface

1. Introduction

The last 8 years have witnessed great strides in our understanding of the pathogenesis, immunology and epidemiology of tuberculosis. In the past decade, after too many decades of inaction, new diagnostics and new treatment regimens for tuberculosis (TB) infection, and drug-resistant TB disease have been developed. This 8th edition of the Canadian Tuberculosis Standards (the Standards) has been extensively revised to incorporate much of this new information, building upon the 7 previous versions of the Standards, which were published in 1972 (with a pediatric supplement in 1974), 1981, 1988, 1996, 2000, 2007 and 2013.

Specifically, in response to feedback from users of previous versions of the Standards, some sections have been expanded, while others have been reduced or eliminated. For example, the chapter on Bacille Calmette-Guérin vaccination has been dropped and updated content is now within the chapter on Pediatric TB. The chapter on disease due to non-tuberculous mycobacteria has also been dropped; some parts are now found in the chapter on diagnosis of TB disease. A new chapter on monitoring TB program performance is a fitting new edition to the Standards (promoting standards for TB programs).

The objective of this document remains to provide practical management information to public health and clinical professionals on all aspects of the pathogenesis, epidemiology, and management of TB in Canada. The guidance pertains to all individuals at risk for or confirmed to have latent or active TB. Specific target users may include: decision-makers, public health professionals, specialists managing TB (eg, internists, respirologists, infectious diseases specialists) and primary care providers.

Of note, the document does not supersede any provincial/territorial legislative, regulatory, policy and practice requirements, or professional guidelines that govern the practice of health professionals in their respective jurisdictions. The Standards also is not intended to replace consultations regarding management of individual patients or other circumstances, between providers and persons with relevant expertise in tuberculosis.

Reference is made to specific tests, procedures and therapies throughout the Standards. For the most part, generic terms are used rather than trade names or manufacturers’ names. However, in a few instances when only a single manufacturer or product is available, a trade name may be mentioned. This is done only to enhance readers’ understanding by providing a name with which they are more likely to be familiar. Use of trade names and commercial sources is for identification only and does not imply endorsement by the Canadian Thoracic Society (CTS).

2. Contributors

3. Acknowledgments

The editor and associate editors are grateful to the many persons and groups who contributed to the development and production of this edition of the Canadian Tuberculosis Standards. These include, but are not limited to, the following:Colleagues in tuberculosis prevention and control programs throughout Canada, many of whom served as authors or co-authorsThe provincial and territorial TB programs that provide non-nominal confidential case reports for national TB surveillance; and the members of the Canadian TB Laboratory Technical Network and their teams for participation in national TB drug resistance surveillanceThe Canadian Thoracic Society staff Janet Sutherland and Anne Van Dam, and members of the CTS Canadian Respiratory Guidelines Committee (CRGC) who made valuable contributions by reviewing the chapters and appendices: Dr. Najib Ayas, Dr. Martin Kolb, Dr. David Zielinski, Dr. Dhenuka Radhakrishnan, Dr. Clare Ramsey, Dr. Christopher Licskai, Lisa Wickerson, Raymond Aceron, Dr. Gail Dechman, and Dr. Erika Penz. CTS would like to acknowledge with sincere appreciation Dr. Samir Gupta (Chair) and Dr. Sanjay Mehta (Vice-Chair) of the CRGC for their expert review and guidance throughout the development process The Association of Medical Microbiology and Infectious Disease (AMMI) Canada, including external reviewers Dr. Fiona Smaill, Dr. Alena Tse-Chang and Dr. Shannon Turvey along with the AMMI Canada Council, Dr. Jared Bullard, Dr. Karen Doucette, Dr. Sarah Forgie, Dr. Todd Hatchette, Dr. Shariq Haider, Dr. Susy Hota, Dr. Philippe Lagacé-Wiens, Dr. Andrew Simor, Dr. Karina Top, Dr. Yves Longtin, Dr. Kelly MacDonald, Dr. Deborah Yamamura and Riccarda Galioto. AMMI Canada would like to extend a special thank you to Dr. Christina Greenaway for her contributions as the liaison representative to the development of this edition of the Canadian Tuberculosis StandardsThe Public Health Agency of Canada (PHAC), including Dr Alanna Fitzgerald-Husek and Dr. Chris ArchibaldIndigenous Services Canada, including Andrea Monahan, Cynthia Tardivel, Kim Daly, Pamela Wolfe-Roberge and Dr. Tom WongThe National Advisory Committee on Infection Prevention and Control, Public Health Agency of CanadaMedical editor: Heather BlumenthalResearch Assistant: Newsha Mahinpey

4. External Reviewers

We are grateful to the following external reviewers for their valuable input:

5. Methodology

As in the past, each chapter is written by authors from across Canada with expertise in the specific topic. The editorial board, comprised of members with broad expertise in clinical and/or public health aspects of TB, reviewed multiple versions of each chapter to ensure optimal clarity and consistency of information and related recommendations. This edition was also developed in collaboration with the Association of Medical Microbiology and Infectious Disease Canada (AMMI Canada), whose expert representatives served as chapter authors and external reviewers.

The Standards were written in 2021. Between January and March 2021, priority content areas were selected by chapter authors with input from the editorial board. The Standards chapters from the 7th edition were evaluated, updates or new sections were added and obsolete sections eliminated based on a consensus of the editorial board and chapter authors and results of a survey of users of the 7th edition of the Canadian TB Standards conducted in 2018-19. Questions of interest were considered in accordance with the PICO method, addressing the Patient group(s) that should be included, the Intervention(s) that should be examined, the Comparison groups that should be part of the studies of the various interventions and the Outcome(s) of interest.

As with previous editions, the 8th edition of the Standards is based upon the best available scientific evidence. Each group of chapter authors conducted literature searches between March to July 2021, for their individual chapters. Authors then carefully reviewed all published evidence, emphasizing the most recent studies, particularly recent systematic reviews. Given the scope of the Standards, with over 120 good practice statements and over 125 different recommendations across 15 chapters, the full GRADE process was not followed. Although formal appraisal tools were not used, each author was required to appraise any included studies for quality of evidence and risk of bias, in order to determine the level of evidence (see the following section). For each recommendation, the panel of authors established a consensus on the strength of the recommendation (either strong or conditional) based on an established framework (see the following section), including their rating of the overall quality of the body of evidence. The recommendations were then vetted by the CTS Canadian Respiratory Guidelines Committee (CRGC) Chair to optimize the language of each recommendation to ensure implementability.

Key points are presented at the top of each chapter. These were selected for emphasis based on a consensus of each chapter’s authors.

5.1. Definitions for statements used in the Standards

Strong recommendation: (“We strongly recommend…”)

Meaning: The action/intervention should be performed in most situations and would be the preferred choice for most individuals. The authors have little doubt that the benefits of the intervention exceed the harms (recommendation “for” the intervention) or that the harms exceed the benefits (recommendation “against” the intervention). The authors judged it unlikely that future studies of the intervention would result in a significant change in the direction or magnitude of the estimated effects (risks and benefits).

These recommendations are usually based on “GOOD” evidence as defined in the following section. Other considerations include greater magnitude of effect and/or magnitude of difference between benefits and harms, alignment with patient values and preferences and strong feasibility based on available resources. These are summarized in the following sections.

Conditional recommendation: (“We conditionally recommend…”)

Meaning: The action/intervention should be considered, based on the likelihood of benefits and harms in an individual patient. The authors concluded that there is likely a net benefit of the intervention, but there is uncertainty about the magnitude of the benefits and/or about whether benefits outweigh the risks. There is reasonable likelihood that new studies could change estimates of the magnitude of risks and benefits (and hence result in modified recommendations).

These recommendations were usually based on “POOR” (or low-quality) evidence. Other considerations included smaller magnitude of differences between benefits and harms, uncertain consistency with individual patient values and preferences and/or uncertain feasibility with respect to resource requirements.

Good practice statement

Meaning: The authors would use the intervention/perform the action in most situations and for most patients. These statements are based on a clear consensus of expert opinion that this action should be beneficial (or harmful, if “against”), but there is minimal or no evidence in support of this. This type of statement is reserved for topics/actions for which there is minimal or no published evidence, and it is considered unlikely that any evidence will be available in the future.

Regulation

A recommendation identified as “regulation” is supported by federal, provincial or territorial legislation from the relevant field of authority (eg, building codes, occupational health and safety) so no strength of evidence is assigned. Regulations are a form of law which define the application and enforcement of legislation. Regulations are made under the authority of an Act and are enacted by the body to whom the authority to make regulations has been delegated, such as a minister, etc.

5.2. Judgements regarding quality of evidence used in the Standards

5.3. Additional considerations that affected author decisions to make strong or conditional recommendations

6. Review and approval process

Each chapter underwent extensive review; all chapters were reviewed by the Editor, at least one Associate Editor and one other chapter author before a 2-day meeting of all authors held on September 23 and 24, 2021. At this meeting, each chapter was presented by authors, followed by the reviewers’ comments, after which all authors provided input. Specific sessions during this meeting were devoted to review of evidence and discussion of recommendations for Directly Observed Treatment (included in Chapter 5: Treatment of TB Disease) and review of evidence for effect of treatment on contagiousness and TB transmission with recommendations for discontinuation of respiratory isolation (included in Appendix B - De-Isolation Review and Recommendations). Consensus was reached on recommendations for these two topics during this meeting.

Following the all-authors’ meeting, each chapter was revised by chapter authors and then reviewed by the Editor. Subsequent revised versions were sent for external reviews by experts in the topic (selected by the Editor and/or the chapter authors). Selected chapters were reviewed by representatives of AMMI Canada, and all chapters were independently reviewed by members of the CRGC. Each reviewer provided a detailed review and suggestions. Authors responded to these reviews, and all reviews, and subsequent revisions were reviewed by the Editor. Upon acceptance, the CRGC recommended approval of the guideline to the CTS Executive Committee.

7. Future updates

The Standards will be formally reviewed every three years or sooner to determine the need for and nature of any updates, in accordance with the CTS Living Guideline Model. Panel members will also use the continuously updated CTS-McMaster Plus database, whereby they will receive alerts when new articles pertaining to key PICO questions are published (starting from the last date of the literature search conducted for this guideline). This will serve to prompt members to consider timely updates with evolving evidence and will facilitate formal literature reviews.

Disclosure statement

The CTS TB Standards editors and authors declared potential conflicts of interest at the time of appointment and these were updated throughout the process in accordance with the CTS Conflict of Interest Disclosure Policy. Individual member conflict of interest statements are posted on the CTS website.

Funding

The 8th edition Canadian Tuberculosis Standards are jointly funded by the Canadian Thoracic Society (CTS) and the Public Health Agency of Canada, edited by the CTS and published by the CTS in collaboration with AMMI Canada. However, it is important to note that the clinical recommendations in the Standards are those of the CTS. The CTS TB Standards editors and authors are accountable to the CTS CRGC and the CTS Board of Directors. The CTS TB Standards editors and authors are functionally and editorially independent from any funding sources and did not receive any direct funding from external sources.

The CTS receives unrestricted grants which are combined into a central operating account to facilitate the knowledge translation activities of the CTS Assemblies and its guideline and standards panels. No corporate funders played any role in the collection, review, analysis or interpretation of the scientific literature or in any decisions regarding the recommendations presented in this document.

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