TB Notes Newsletter

No. 4, 2011

NEWS FROM THE DIVISION OF TUBERCULOSIS ELIMINATION

Guidelines Released on New, Shorter Regimen for LTBI

These are exciting times in TB control! Global resource-sharing partnerships are speeding up progress; new technologies are providing faster and more accurate diagnoses; and better drugs are making their way into the research pipeline. And while finding and curing TB is the first goal of TB control, preventing TB by treating latent TB infection (LTBI) is also a cornerstone of the U.S. TB elimination strategy. The Division of Tuberculosis Elimination is pleased to announce the December 2011 release of guidelines for using a new two-drug, 12-dose regimen for preventing TB disease. The guidelines are based on three randomized controlled trials, especially a 10-year, 8,000-patient study that was carried out by CDC’s TB Trials Consortium (TBTC), “TBTC Study 26, PREVENT TB.” The recommendations are available in CDC’s Morbidity and Mortality Weekly Report (MMWR) dated Dec. 9, 2011.¹

The New LTBI Recommendation
The treatment trials showed that a regimen of isoniazid (INH) and rifapentine (RPT) taken once weekly for 12 weeks as directly observed therapy (DOT) is well tolerated, is as effective in preventing TB as other regimens, and has greater completion rates than 9 months of INH given without DOT. CDC recommends this regimen as an equal option for most persons diagnosed with LTBI who are at least 12 years old, with caveats listed below. The weekly dose is 900 mg INH and 900 mg RPT for persons weighing at least 50 mg (110 pounds). Please refer to the MMWR guidelines for specifics before prescribing the new regimen or making any programmatic changes.

Examples of settings in which the regimen offers advantages:

• Correctional settings
• Clinics for recent immigrants
• Homeless shelters

Persons for whom the regimen is not recommended:

• Children younger than 2 yrs
• HIV-infected persons taking antiretroviral therapy
• Women who are pregnant or expect to become pregnant during treatment
• Persons with LTBI with presumed INH- or RIF-resistant organisms.

Important things to keep in mind

• RPT induces or speeds up the metabolism of many drugs.
• Missed doses and other regimen alterations could lessen effectiveness or cause adverse effects: use DOT.
• Patients should receive clinical evaluations at least monthly.
• Patients should be educated about adverse events and asked about symptoms at each DOT encounter and at clinical evaluation visits.
• Patients with the following conditions should undergo baseline blood tests, and then follow-up tests as clinically indicated:
• HIV infection
• Liver disorders
• Regular alcohol usage

What About Previous LTBI Recommendations?
CDC’s previous recommendations for LTBI treatment regimens are unchanged. The recommendations for the new regimen do not replace the guidance for using 9 months of isoniazid; rather, they give clinicians another option for treating LTBI. The standard 9-month regimen has been shown to prevent TB in most groups, including children and HIV-infected persons, and is highly efficacious. The 9-mo INH regimen can still be used; however, the long treatment duration and rare but serious cases of liver injury have been long-time barriers to its use. When INH cannot be used, a daily, 4-month regimen of rifampin (6 months for children) is still recommended.² The RIF/PZA regimen² is not recommended.

The new regimen was well tolerated in trials, and the most notable adverse effects were episodes of reversible hypotension, possibly indicating hypersensitivity. Adverse effects leading to hospital admission or death should be reported to local or state health departments for inclusion in this system (e-mail: LTBIdrugevents@cdc.gov). Adverse events or medication errors also should be reported to FDA MedWatch by submitting a MedWatch Form 3500 or by calling 1-800-FDA-1088.

—Reported by John Jereb, Krista Powell, Stefan Goldberg, M. Elsa Villarino, and Philip LoBue
Div of TB Elimination

References

1. CDC. Guidelines for a combination regimen of isoniazid and rifapentine in 12 once-weekly doses under direct observation for treating latent Mycobacterium tuberculosis infection. MMWR 2011 Dec. 9; 60 (RR–#).
2. CDC. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR 2000; 49 (RR–6).

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DTBE Training Course on Quality Assurance for Tuberculosis Surveillance Data

Background
During the past several years, an interdisciplinary team at DTBE has been conducting training on the definitions and instructions for the Report of Verified Case of Tuberculosis (RVCT) data collection form.^{1, 2} As a logical follow-up to the RVCT training, the RVCT training team submitted a proposal that was funded by DTBE to conduct a quality assurance (QA) training course for the 60 reporting areas of the National Tuberculosis Surveillance System (NTSS).

The team used the systematic health education process3 to develop the QA course. This five-step process includes:

• Needs assessment
• Development
• Pilot test
• Implementation
• Outcome/impact evaluation

Needs Assessment
During 2010–2011, the RVCT QA training team conducted a comprehensive needs assessment to guide the design and development of the RVCT QA training course. The needs assessment included

• Collaborating with TB program staff from low, medium, and high TB-burden jurisdictions to prioritize QA components; determine a QA process; and collect existing tools used for QA. The team obtained information via site visits and conference calls;
• Meeting with surveillance staff from other CDC divisions such as the Division of STD Prevention, the Division of HIV/AIDS Prevention, and the Division of Viral Hepatitis to gather available QA materials;
• Reviewing published QA materials from various agencies;
• Reviewing the CDC TB cooperative agreement (CoAg), as well as reviewing the progress reports from the funded sites; and
• Prioritizing components and tools to include in the training.

The needs assessment identified five major QA components to cover in the course

• Case detection
• Data accuracy
• Data timeliness
• Data completeness
• Data security and confidentiality

Development

The RVCT QA training team used the results of the needs assessment and collaborated with other DTBE faculty (subject matter experts) to develop the content for each of the five components of the QA process. The course format included the following activities:

• Presentations from faculty
• Slides
• Handouts
• Exercises to apply the content
• Discussions to share experiences and expertise on the QA components
• Tools for jurisdictions to use and adapt to their setting
• End-of-course evaluation to obtain feedback from participants about the course

Presentations from faculty
Presentations were developed by the faculty for their assigned section of the course, including the QA process, sample studies, and recommendations. The following materials were also developed:

Slides
PowerPoint slides emphasized key points and provided visuals to explain the concepts.

Handouts for the presentations
The handouts included printed copies of the slides, exercises, and other relevant materials. These will be used in the future to develop the QA manual.

Exercises
Various exercises were designed to help course participants apply the content to life-like situations by solving case studies, identifying problems with data, and calculating timing issues.

Discussions
The team designed discussion sessions to provide an interactive course where participants could share their expertise and experiences. This would create an engaging environment conducive to learning and networking. In addition to asking questions to clarify content, participants would have the opportunity to describe how they conduct QA at their jurisdictions and provide examples of QA challenges they encounter.

Tools
An important part of the training curriculum was the 47 QA tools that jurisdictions can adapt to their settings. The tools include tables, charts, graphs, templates, and processes that are in commonly used electronic formats. They were developed by staff from CDC and individuals from various jurisdictions including Jason Cummins (TN), Sheanne Allen (WA), Jill Fournier (NH), Eyal Oren (Seattle/King County, WA), Janice Westenhouse (CA), and Gayle Wainwright (OR). One of the main tools is a template developed by the RVCT QA training team to help jurisdictions write a QA protocol that is required in the CoAg.

Pilot Test
In July 2011, the team facilitated a pilot test of the QA Course. Eleven participants from various state and local health departments were involved in the pilot test. Many of the participants were also involved in the needs assessment. The course was presented and participants provided suggestions on what went well, as well as how to improve the materials, the presentations, and the schedule and flow of the course. The evaluation included end-of-section and end-of-course evaluations, as well as observations by course faculty. The course was revised based on the analysis of the evaluation results.

Implementation
The RVCT QA training team (Lilia Manangan, Elvin Magee, and Cheryl Tryon) and other faculty members conducted four 2-day trainings in Atlanta, GA, between July and September 2011. A total of 75 staff from 35 (58%) of 60 jurisdictions were trained.  Eleven of the participants were involved in the pilot test.

Other faculty included Roque Miramontes (Introduction/QA), Sandy Price/Stacey Parker (Data Flow and System QA Reports), Bob Pratt (Data Accuracy), Lori Armstrong (Data Validation Pilot Project), Carla Jeffries (Missing and Unknown Report), Beverly Metchock/Angela Starks (Laboratory), Glenda Newell (Case Count Timeliness), Kai Young (National TB Indicators Project), Rachel Yelk-Woodruff (RVCT Completeness Study), and Juliana Grant/Sandy Althomsons/Brian Baker (TB GIMS).

Course Evaluation
Participants from the four trainings completed an end-of-course evaluation form consisting of objective and non-objective questions. Results of the evaluations indicated that participants learned about the QA process and liked sharing information on how other jurisdictions implement the QA components. They also valued the QA tools and are looking forward to using them in their setting. Participants stated that some of the most important things they learned were the five QA components and how they relate to the requirements in the CoAg and the written QA protocol. Most of the participants appreciated the thought and hard work that went into implementing the course and want this to continue. Selected participant comments include:

• “I learned a great deal from this pilot.  This course will be valuable to the states and will lead to great discussions and changes in the way QA is performed.  This will therefore lead to great improvement in the quality of the data.”
• “Very informative – lots of info I can actually use and apply to day-to-day activities (i.e., tools)”
• “Identified a number of good suggestions on how to improve my state’s level of accuracy with new tools provided by different topic speakers.”
• “Great job! Please continue this class. It was very informative and I learned a lot.”

Future activities
Develop a QA manual — A QA manual will be developed that can be used as a reference guide and training manual. It will include many of the handouts developed for the course, exercises to apply the content, glossary, and examples of the tools. A CD will provide the tools so that jurisdictions can use them and adapt them to their setting. The print version of the manual will be available in 2012 and will also be available for downloading from the CDC DTBE website.

Possibly provide a few additional trainings and webinars — Course participants have requested that the QA course be repeated in the future and a series of webinars be developed. These will provide learning opportunities for others who could not attend this year. The QA training team is determining the feasibility for conducting these additional activities.

—Reported by DTBE’s RVCT QA Training Team:
Lilia Manangan, Elvin Magee, Cheryl Tryon
Div of TB Elimination

References

1. CDC. DTBE’s Comprehensive and Innovative Training Program on the Revised RVCT. TB Notes Newsletter, No. 3, 2009.
2. Magee E, Tryon C, Forbes A, Heath B, Manangan L. The National Tuberculosis Surveillance System Training Program to Ensure Accuracy of Tuberculosis Surveillance Data. J Public Health Management Practice, 2011, 17(5), 427–430.
3. National Institutes of Health. The Pink Book – Making Health Communication Programs Work; National Cancer Institute; U.S. National Institutes of Health; 

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