MDR-TB Planning Toolkit
Version No. 2 February 2012
MDR-TB Planning Toolkit
Acknowledgments PATH prepared this document with funding from the United States Agency for International Development (USAID) under the Tuberculosis Indefinite Quantity Contract (TB IQC) Task Order 01 (TO2015), GHN-I-00-09-00006-01.
The World Health Organization (WHO) focal points for this project are Tauhid Islam and Wieslaw Jakubowiak, with input from Ines Garcia Baena. Its primary author is Sarah Royce (University of California, San Francisco). The PATH team includes D’Arcy Richardson, Lisa Mueller, Lesley Reed, and Katherine Doyle. PATH would like to acknowledge the following for their helpful contributions: G.B. Migliori (Fondazione Salvatore Maugeri) and D’Arcy Richardson for creating the original MDR-TB assessment tool on which this toolkit was built; the Green Light Committee Secretariat; participants and facilitators in the October 2010 WHO drug-resistant TB consultants course in Ahmedabad, India (Puneet Dewan, Md. Khurshid Alam Hyder, Malik Parmar, Rose Pray, Maria Imelda Quelapio, Ranjani Ramachandran, and Fraser Wares); Vineet Bhatia; Fabio Luelmo; Thomas Moore; Amy Piatek; Giovanni Sotgiu; and Celia Woodfill. PATH gratefully acknowledges Charles Sandy and Godfrey Mutetse of the Zimbabwe Ministry of Health and Child Welfare for providing important feedback after testing the tools in a stakeholders’ workshop in Harare in February 2011.
For further information on this toolkit, please contact D'Arcy Richardson (PATH) at [email protected] or Tauhid Islam (WHO) at [email protected].
Version No. 2, February 2012 Introduction and user’s guide 2 MDR-TB Planning Toolkit
MDR-TB Planning Toolkit
Welcome to the MDR-TB Planning Toolkit. This set of tools is designed to help countries develop or strengthen a multidrug-resistant tuberculosis (MDR-TB) control component within their national TB strategy or plan. The toolkit contains key steps for the planning process, including developing objectives for a strong MDR-TB control component, identifying current gaps in service coverage, securing funding sources, and determining how to monitor progress.
The MDR-TB toolkit is intended for countries, technical partners, international organizations, and donors who want to improve the detection and treatment of drug-resistant TB. It draws together existing guidance from international organizations (including the World Health Organization [WHO]), the Green Light Committee, and the Global Fund to Fight AIDS, Tuberculosis and Malaria [Global Fund]) to create an easy-to-follow process.
The tools can be used for countries that are forming their first MDR-TB plan, as well as countries revisiting an existing plan. The tools also work for developing different types of plans, ranging from a long-term strategy for achieving universal coverage to a short-term plan that implements a particular phase of that strategy. They can form the basis of an application to the Global Fund or to other donors. Ultimately, the toolkit’s aim is to help countries achieve the goal of providing universal access to high-quality care for people with drug-resistant TB.
This toolkit starts with the assumption that the national TB strategy is already addressing the detection and treatment of TB. Basic directly observed therapy, short-course (DOTS) programs are essential for reducing the burden of MDR-TB. In order to prevent drug resistance from developing in the first place, TB patients need interventions such as standard regimens of quality assured medicines, support, and supervision. Similarly, strong systems for suspecting and detecting TB are a prerequisite to detecting multidrug resistance. The detection and treatment of TB are outside the scope of this toolkit. Instead, this toolkit focuses on detecting and curing existing MDR-TB cases and stopping its spread to others. Of course, the relative priority of activities to control MDR-TB will need to be considered in the context of the country’s TB strategy. How to Use the MDR-TB Planning Toolkit Each of the eight tools asks key questions that need to be answered to create an effective MDR-TB response within your national TB strategy. Worksheets are provided to help your team address these questions, design a plan of action, and come to a consensus on next steps. Each worksheet is designed to become part of your final MDR-TB control plan, so as you are working through this toolkit, you are creating your plan. At the end of the toolkit, you will find other useful resources, including references to WHO recommendations.
Because each country is at a different place in the planning process, choose the tools that meet your particular needs. You can work through the tools as presented here, or you can tailor them to fit the process you design. If you are at the beginning of the process, you may want to follow these tools step by step. If you are further down the road (scaling up an already existing program, for example), some
Version No. 2, February 2012 Introduction and user’s guide 3 MDR-TB Planning Toolkit steps may not be necessary. You may also find that certain tools need to be revisited a number of times over the course of planning and implementing services.
If your country’s national TB strategy already contains elements to control MDR-TB, you can choose to start with Tool 8 to assess the strength of your existing MDR-TB plans and then work through relevant sections of the toolkit to strengthen your plan. Urgent needs to scale up coverage, technology innovations, or new epidemiologic data may also prompt the need to revisit an existing plan.
Note about “Plan” versus “Strategy”: Scaling up the diagnosis and treatment of MDR-TB requires detailed planning. The International Health Partnership (IHP+)1 defines a Plan as a document, or set of documents, that provides details of how objectives are to be achieved, time frame for work, who is responsible and how much it will cost. This may be in the form of a multi-year plan, supported by annual operational (or work) plans. (This is in contrast to a Strategy, which IHP+ defines as providing the big picture: the context, vision, priorities, objectives and key interventions to inform more detailed planning documents.) The Tools Tool 1: Prepare for the planning process...... 7 Key questions: Why create or revise an MDR-TB control plan? How will it fit with other health plans? Who needs to participate? Worksheet 1A: Get Ready...... 8 Instructions for Worksheet 1B: Task Timeline for Developing and Disseminating the Plan...... 10 Worksheet 1B: Task Timeline for Developing and Disseminating the Plan...... 10 Tool 2: Develop objectives and provisional targets...... 11 Key questions: What would success look like? How will activities contribute to results? How will results be measured? Instructions for Worksheet 2: Preliminary Results Framework...... 13 Worksheet 2 : Preliminary Results Framework...... 18 Tool 3: Analyze the current situation...... 19 Key questions: What is the MDR-TB situation now? Where are the gaps in control measures? Instructions for Checklist 3: Essential Elements for MDR-TB Control...... 20 Checklist 3 : Essential Elements for MDR-TB Control...... 22 Tool 4: Prioritize gaps...... 27
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Key question: Which are the most important gaps in MDR-TB control to address first? Instructions for Worksheet 4: Set Priorities...... 27 Worksheet 4 : Set Priorities...... 28 Tool 5: Design activities to address priority gaps...... 29 Key questions: Why are there gaps in MDR-TB control? What should be done to overcome obstacles? Instructions for Worksheet 5: Understand the Gaps and Design Interventions...... 29 Worksheet 5 : Understand the Gaps and Design Interventions...... 31 Tool 6: Finalize goal, objectives, and targets...... 32 Key questions: Will planned activities lead to desired results? How much will be accomplished each year? Instructions for Worksheet 6A: Final Results Framework...... 32 Worksheet 6A : Final Results Framework...... 33 Instructions for Worksheet 6B: Final Goal and Objectives...... 34 Worksheet 6B : Final Goal and Objectives...... 37 Instructions for Worksheet 6C: Interim Targets During the Life of the Plan...... 38 Worksheet 6C : Interim Targets During the Life of the Plan...... 38 Tool 7: Budget and assemble the plan...... 39 Key questions: How much will it cost to implement each activity? Who will take responsibility for implementing which activities? Instructions for Worksheet 7: Activities, Budget, and Implementers Worksheet...... 39 Worksheet 7 : Activities, Budget, and Implementers Worksheet...... 40 Assemble your plan...... 40 Tool 8: Review the plan...... 42 Key question: Does the MDR-TB control component of a national TB strategy contain the key ingredients of a sound plan? Instructions for Worksheet 8: Assess the MDR-TB Component of a National TB Control Plan...... 43
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Worksheet 8 : Assess the MDR-TB Component of a National TB Control Plan...... 44 Annexes Annex A. Acronyms and abbreviations...... 50 Annex B. Options for where to place MDR-TB elements within a national stop TB plan (Supplement to Tool 7)...... 51 Annex C. MDR-TB Control Essential Elements Reference List (Supplement to Checklist 3)...... 52 Annex D. References...... 60
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Tool 1: Prepare for the planning process
Before you begin planning to create or revise an MDR-TB component plan, it’s important to think about some key issues. These include:
Are there already elements to control MDR-TB in the national TB plan? Why is a (revised) plan for MDR-TB control necessary? How will (does) it fit into the country’s TB and health sector plans, and the region’s MDR-TB response plan (if there is one)? 2–4,6,7
Who needs to participate and is there support? What are the steps necessary to produce the plan? Who will pay for the planning costs? This toolkit is designed to integrate activities to detect and treat MDR-TB within the country’s overall TB plan. Furthermore, WHO recommends that national TB plans be consistent with a country’s overall health development plan and with global TB targets and objectives.5 There should be clear links with related national plans, such as those addressing HIV, human resource development, laboratory strengthening, and infection control. Several WHO regions have MDR-TB response plans that provide guidance to country level planning efforts.2–4,6,7
Many countries convene a core planning team to design and steer the planning process. When this toolkit uses the term “you,” think “the planning team.” Usually the planning team is led by the national TB program (NTP) within a country’s ministry of health (MOH), and the MOH “owns” the plan. However, this toolkit can also be used to develop or revise a sub-national plan, in which case you will substitute “MOH” with the appropriate health authority at the regional or provincial level.
It is essential to engage stakeholders in the planning process. “Participatory approaches generate political commitment, build ownership and create champions, ensuring that the issues raised are considered from multiple perspectives,” according to WHO.8 If the process only includes technical experts, interventions may prove to be unacceptable or unable to address the needs of beneficiary communities or other important stakeholders.
This section includes two worksheets:
The Get Ready worksheet will help you think through the purpose of your MDR-TB plan, how the plan will fit with other national plans, who to involve in planning, and the costs and support required to develop the plan. In addition to helping you prepare for the planning process, your responses to many of the questions can form the basis for your plan’s introduction. (See sample plan outline in Tool 7).
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The Task Timeline worksheet will help you define the steps necessary to produce the plan, develop a timeline, and budget the costs of developing the plan. Worksheet 1A: Get Ready Complete this worksheet before you begin the planning process.
A. Plan context
1. What is the purpose of the plan?
2. What is the time frame for the plan?
Start date (date first activities will begin)______End date______
3. If there is already an MDR-TB component in the national TB plan, what is prompting the need to revise it? (Examples include the need for more rapid scale-up, policy changes, new epidemiologic data, and technological innovations.)
4. How will this MDR-TB control plan fit within: a. The national TB plan? (See Annex B for some options to consider.)
b. The overall health sector plan?
c. The country’s overarching national development objectives?
5. How will the MDR-TB plan link with related national plans (such as HIV/AIDS, laboratory strengthening, and human resource development)?
6. How will it help implement the region’s MDR-TB response plan2–4,6,7 (if there is one)?
B. Support for and participation in planning
1. Do you have support from the appropriate levels of the MOH for the planning effort? If not, how will this be secured?
2. Do you have MOH commitment to endorse and implement the plan?
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3. Use the chart below to list key government agencies (ministries of health, planning, justice, etc.), civil society partners, groups, or individuals representing people impacted by TB and/or HIV, and private providers that should be involved in the planning process. Think about different levels to include in developing the plan (national, provincial, district, community). Add the names of key individuals to contact and secure their commitment to participate in the planning process. Add lines as needed.
Agencies, partners, groups, etc. to include in planning process Individuals to contact
4. How much will it cost to develop the plan (including travel and meeting space)? How much will it cost to disseminate the plan? (Use Worksheet 1B—the Task Timeline worksheet—to create a budget for the planning process.)
5. Who will pay the planning costs?
6. Who will manage the planning resources?
C. Securing commitments of agencies and resources
1. What steps will be taken to secure NTP and stakeholder commitments to carry out the particular activities suggested for them?
2. How will a financial gap analysis be conducted (i.e., determining the resources needed for each activity and comparing to available resources from NTP or partners)? (See Worksheet 7.)
3. Once the funding gaps are defined, what steps are necessary to secure the needed resources to fill the gaps and implement the plan?
4. What are the steps to secure MOH endorsement?
5. Will you seek endorsement from sub-national health authorities?
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6. Will other stakeholders endorse the plan? If so, what steps need to be taken to secure their endorsement?
7. How will the plan be released and disseminated?
8. Who will participate in the first (and regularly scheduled) meetings to review implementation and monitor the plan?
Instructions for Worksheet 1B: Task Timeline for Developing and Disseminating the Plan The Task Timeline will help you structure your planning process by answering four key questions: What steps are you envisioning for the planning process? What are your projected due dates for each step? Who will be responsible for each task? What is the estimated cost of each task?
Add lines as needed to include such important tasks as:
Securing MOH support/commitment. Contacting people to join the planning team and participate in the planning process. Securing commitment from agencies and the resources required to implement the plan. Conducting a financial gap analysis. Assembling the plan. Securing ministry endorsement. Disseminating the plan. Monitoring implementation of the plan.
Worksheet 1B: Task Timeline for Developing and Disseminating the Plan Planning task Due date Who will be responsible for the Cost of this task task?
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Tool 2: Develop objectives and provisional targets
This tool and worksheet will help you select objectives and set provisional targets at the start of the planning process. The Results Framework worksheet will help you address these questions:
What would success look like? How will activities contribute to outputs, outcomes, and impact? How will results be measured? The Results Chain Before you start the Results Framework worksheet, it’s helpful to consider a results chain.9,10 A results chain describes a sequence of events that lead to desired results.
Processes Results Inputs (Activities) (Outputs Outcomes Impact)
Inputs are required to conduct the planned activities. The processes are the activities used to achieve the desired results. The results can be immediate/short-term (also called outputs), medium-term (outcomes), or long-term (impact). The short-term results should contribute to the medium-term results, which in turn should contribute to the long-term impact.
To improve MDR-TB case detection, for example, inputs might include the development of training curricula. Activities might include improving laboratory capacity by training laboratory staff. These, in turn, will lead to results, such as increased MDR-TB testing of patients (output), which will lead to increased detection of MDR-TB (outcome) so patients can be treated, thus reducing the spread or burden of MDR-TB (impact).11,12 The Results Framework This results chain of events can be displayed in a Results Framework, which further details the strategies and activities that will be taken to reach the intended results (outputs, outcomes, and impact). It shows the causal pathways that lead to the desired impact. Think of this as the logic that underpins the plan. (The Results Framework is also called a “logic model” or monitoring and evaluation [M&E] framework.10,12,13)
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Below is a Sample Results Framework for the detection and treatment of MDR-TB. (The Results Framework worksheet follows.) The numbers and letters in parentheses correspond to components of WHO’s Stop TB Strategy.14 The sample includes broad categories of activities, which should be replaced by country-specific activities that Tool 5 can help you develop. Sample Results Framework Broad categories of activitiesa Outputs Outcomes Impact
Lab infrastructure (1B) Increased # of patients Increased # of MDR- tested for MDR-TB TB cases detected Priorities and mechanisms for MDR-TB testing (1B)
Decreased burden MDR-TB patient support, monitoring (1C) Increased # of MDR-TB Increased # of MDR- of MDR-TB patients starting TB cases successfully TB patients know their HIV status (2A) treatment treatedb Community-based MDR-TB care (5)
Regular supply of high-quality second-line drugs (1D)
The Results Framework can be modified according to your country’s situation. For example, you can adapt the framework by adding a column to the left to display inputs. You can also include activities under the additional Stop TB Strategies listed below. These are “cross- cutting” in that they usually contribute to more than one output or outcome.
Political commitment, advocacy (1A, 5)Error: Reference source not found M&E, supervision (1E) Human resources development (3A) Infection control (3B) Engage all providers (4) Empower communities (5)
a Stop TB Strategy components are in parentheses after each line. b See Annex C, Section 1C for sample interim indicators, such as percent with negative cultures at month six, or percent died or defaulted at month six.
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Operations research (6)
The framework can also be modified to list activities and outputs leading to:
Detection of TB cases, which is a necessary precondition to detecting MDR-TB. Prevention of acquired drug resistance among TB patients undergoing treatment with first-line medicines. This requires appropriate regimens and quality of drugs, good case management and supervision, etc. TB patients knowing their HIV status and, if positive, submitting specimens for MDR-TB testing and starting on antiretroviral therapy (ART) and cotrimoxazole.
Setting Preliminary Targets Each of your outputs and outcomes should have targets that answer the question: What do you intend to achieve? Targets are based on the country’s current baseline coverage, the gaps in coverage, and the anticipated pace of scale-up (taking into account available resources and the feasibility of overcoming obstacles or constraints). Targets13 should be:
Ambitious but realistic. Relevant (matching priority needs). Clear and measurable. Set through a participatory process involving all stakeholders who agree to use the same set of targets. (See Tool 1.) The targets you’ll set in Worksheet 2 (below) are preliminary targets. Later in the planning process, Tool 3 will help you analyze the country’s current MDR-TB service coverage and gaps in more detail, and Tool 5 will help you take stock of current constraints. Then Tool 6 will ask you to revisit the provisional targets set here and finalize them. You can also use Tool 6 to return to the Results Framework to check that your activities are likely to bring about the desired outputs and that, if these outputs are achieved, they will lead to the desired outcomes and impact. Instructions for Worksheet 2: Preliminary Results Framework Refer to the Results Framework worksheet (which follows the instructions) as you read through these detailed instructions. The Results Framework is filled out from right to left. The goal (desired impact) is set first. Then the planning team considers the intermediate outcomes and short-term outputs needed to achieve the long-term impact. The numbers in the boxes of the worksheet correspond to the steps in the instructions.
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1. Select a goal and describe the desired overall impact. The Global Plan to Stop TB 2011-2015 includes the goal of reducing the burden of drug-resistant TB15 in order to save lives and protect communities.16 Countries can set a similar goal for their national plans. This is the long-term impact the plan should have. A general goal statement has been entered in Box 1 of the worksheet above as a “placeholder.” Later in the planning process, Tool 6 includes suggestions on how to measure impact.
2. Select your outcome objectives to reach the goal. In order to achieve the ultimate impact of saving lives and protecting communities, the World Health Assembly urges member states to achieve universal access to MDR-TB diagnosis and treatment.16 Thus, key outcomes (or medium-term objectives) are the detection and successful treatment of MDR-TB cases, both of which are indicators in the Global Plan.15 These are comparable to the familiar TB outcome measures of TB case detection and treatment success. These two outcome indicators have already been entered in boxes 2.1 and 2.2 in the Preliminary Results Framework (Worksheet 2).
Now you can set your targets for these outcome indicators.
Box 2.1. Determine your preliminary target for the number of MDR-TB cases to detect. In the final year of this plan, how many MDR-TB patients do you want to detect? To help you answer this question, consider the following:
Baseline: How many MDR-TB cases were detected in the most recent year with available data? The number of notified MDR-TB cases your country reported to WHO is posted on the WHO website.17,18 This is your baseline to fill in Box 2.1 of the Preliminary Results Framework. Target: What is the WHO estimate of the number of MDR-TB cases that could be found each year if all new pulmonary and re- treatment notification were tested for MDR-TB? This shows you what it would mean to have universal access to diagnosis among these notified TB cases. WHO publishes these estimates for each country each year.17 How many of these estimated MDR-TB patients can be detected in the final year of the plan? To set a preliminary target, consider the pace of scale-up18 while taking into account the resources you can mobilize and the feasibility of overcoming obstacles. Fill in the blank in Box 2.1 with the target for the number of MDR-TB patients to detect in the final year of the plan. You can also express the target as a percent of the WHO estimate. (See Worksheet 6B.)
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Box 2.2. Determine your preliminary target for percent of MDR-TB patients who will be successfully treated.
Note: In this worksheet, MDR-TB treatment success is expressed as a percent while the other targets are expressed as numbers. In Tool 6, the other indicators are also translated into percent of patients served. Baseline: For the baseline in Box 2.2, fill in the percent of the most recent MDR-TB cohort that had successful outcomes (cure or completed treatment). WHO posts these reports from countries online.18 If MDR-TB patients’ treatment outcomes are not yet available for your country, you can set targets using interim outcomes described in Annex C, Section 1C (for example, the percent with negative culture at six months).11,19 You can also look at data from countries with comparable programs.20 Target: To set the preliminary target for treatment success, discuss initial thoughts about the MDR-TB patients with unfavorable outcomes. The proportion of MDR-TB patients with these unfavorable outcomes is posted online18: o Died. o Defaulted from therapy. o Failed therapy. o No outcome is available. How and to what extent can the unfavorable outcomes be prevented? (You can explore this more fully with Tools 3 and 5.) For example, if there is a large percent defaulting and the causes are amenable to intervention, you would set a high target for treatment success. You might set a lower target if a large proportion has transferred out due to migration out of the country, which makes it difficult to obtain final outcomes. 3. Select your output objectives to help you achieve the desired outcomes . To detect MDR-TB cases, patients with suspected MDR-TB must, of course, be identified and tested. And to achieve treatment success, the MDR-TB patient must first be enrolled in appropriate treatment. Testing patients and enrolling those found to have MDR- TB are the critical outputs (or short-term objectives), both of which are indicators in the Global Plan.15 These outputs have already been filled into boxes 3.1 and 3.2 in the Preliminary Results Framework (Worksheet 2). Box 3.1. Determine your preliminary target for number of patients to test for MDR-TB. WHO recommends that countries perform MDR-TB testing on all TB patients who have been previously treated, since levels of MDR- TB are much higher in this patient group than in new TB patients.21 Sputum specimens should be sent to the laboratory (for culture and drug susceptibility testing [DST] or molecular testing) before or at the time re-treatment is initiated. Previously treated patients include three subgroups: TB patients whose treatment is failing, who return to care after defaulting, or who have relapsed.
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Baseline: Fill in the number of MDR-TB tests performed in the most recent year in re-treatment patients.17,18 Target: In order to diagnose the target number of MDR-TB cases you set in Box 2.1, you will need drug susceptibility testing of a certain number of re-treatment patients (which will be the target for Box 3.1). You can calculate this by dividing the number of MDR-TB patients to diagnose (Box 2.1 target) by the proportion of previously treated patients found to have MDR-TB in your country’s most recent drug resistance survey (DRS).17,22 (Express this proportion from your DRS as a decimal i.e., 10 percent would be expressed as 0.10.)
Discuss your initial thoughts on whether testing this number of re-treatment patients is achievable for the final year of your plan given your MDR-TB case finding strategy. For example, some countries start with an MDR-TB case finding strategy limited to patients whose treatment is failing. Broadening the strategy to all previously treated patients will enable the country to find many more MDR-TB cases. The target also depends on what laboratory method your country is using and what proportion of samples yield a result. For example, conventional drug susceptibility testing can only be performed when a culture is found to be growing. If you increase (or decrease) your preliminary target for Box 3.1, you will need to adjust your Box 2.1 target.
Note: Box 3.1 is “previously treated patients with MDR-TB testing” because this is a high priority group to test, and is a Global Plan15 indicator for which countries routinely report their performance each year. However, some countries may want to replace this with the broader group: “patients with suspected MDR-TB who undergo DST.”
Limiting DST to re-treatment patients will miss MDR-TB cases among patients with no prior TB treatment, who comprise a significant fraction of some countries’ MDR-TB cases.17
WHO recommends prioritizing DST of certain groups of new TB patients: those in contact with known MDR-TB cases and/or those living with HIV.21
The Global Plan 2015 target is for DST of at least 20% of all new patients,15 but some countries plan to test all smear positive new cases. Modelling found that rapid testing for both isoniazid and rifampicin resistance at the time of TB diagnosis is the most cost-effective testing strategy for any patient group, even at very low levels of resistance among TB patients (MDR-TB in > 1% and isoniazid resistance other than MDR-TB in > 2%23). These levels of drug resistance are found in many countries’ new TB patients.
Box 3.2. Determine your preliminary target for # of MDR-TB patients started on MDR treatment.
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Since all detected MDR-TB patients must be offered treatment, set the same target for the number of confirmed MDR-TB patients to enroll into treatment (in Box 3.2) as you set for the number of MDR-TB cases to be detected (in Box 2.1). Detection and enrollment need to stay aligned during the planning process. Activities to expand enrollment speed and capacity need to keep pace with increased detection.
4. Design activities to help you achieve your output objectives. You can leave boxes 4.1 and 4.2 blank for now. Tool 3 will help you assess country performance gaps which you’ll prioritize using Tool 4. After using Tool 5 to design activities to address prioritized gaps, you can insert the activities in boxes 4.1–4.2 in the final Results Framework in Tool 6.
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Worksheet 2: Preliminary Results Framework Note: The numbers in the boxes correspond to the steps described in the instructions above. You will be working from right (Box 1) to left (Box 2, then 3) to fill out this framework.
Activities Outputs Outcomes Impact
4.1 3.1 # of previously treated patients with 2.1 # of MDR-TB cases detected MDR-TB testing Baseline: __ (year) Baseline: __ (year) Target: __* (final year of plan) Target: __ (final year of plan) 1. Decreased 4.2 3.2 # of MDR-TB patients starting 2.2. % of MDR-TB cases successfully burden of MDR-TB treatment treated
Baseline: __ (year) Baseline: __ (year)
Target: __* (final year of plan) Target: __ (final year of plan)
*Since all confirmed MDR-TB cases need to be treated, the targets for Box 2.1 and 3.2 should be the same number of MDR-TB patients.
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Tool 3: Analyze the current situation
Now that you have set preliminary objectives for your plan, the rest of the planning process is about how to achieve them. To decide which activities are necessary to reach your objectives, you will first need to assess the country’s progress to date toward achieving universal access to MDR-TB diagnosis and treatment. Key questions at this stage of the planning process include:
What is the MDR-TB situation now? How well is the country currently detecting and treating MDR-TB? What are the gaps in MDR-TB control measures? Overview of Checklist 3: Essentials Elements for MDR-TB Control This Essentials Elements for MDR-TB Control checklist will help you quantify the gap between the current performance and the target. Once you’ve determined the gaps in current MDR-TB services, you can decide which gaps are most important to address (Tool 4) and then design activities to address those gaps (Tool 5).
This checklist consists of all relevant WHO recommendations essential for scaling up the detection and treatment of MDR-TB. Each recommendation (“essential element”) is phrased as a result to be realized as part of a country’s overall TB plan. Each essential element is displayed as a row, distributed across all components of the global Stop TB Strategy.14
The checklist is limited to elements necessary for the detection and treatment of drug-resistant TB. Since it is designed to fit into an overall country TB plan, this toolkit assumes the rest of the country’s TB plan will cover all other TB-related elements. For example, in order to detect MDR-TB, tuberculosis must be suspected. In order to prevent drug resistance from developing during the treatment of TB cases, patients need standard regimens with quality-assured drugs, support, supervision, etc. These are two examples of elements of a TB program that are essential for reducing the burden of MDR-TB, but they are outside the scope of this toolkit. (Other tools are available to help you assess the overall TB situation.24–26)
Under each Stop TB Strategy component, Checklist 3 breaks the essential elements down into “First steps” and “Next steps” required to achieve universal access to MDR-TB diagnosis and treatment. The division of WHO recommendations into first and next steps is designed to help countries sequence their initiation and scale-up process. “First steps” consist of basic elements that serve as the starting point for countries initiating the diagnosis and treatment of MDR-TB. Once a country’s minimum essential elements are in place, the “Next steps” are recommended for phase-in. However, at any step in a country’s path toward universal access, the country may choose elements from “Next steps” that it judges to be high priority and feasible to implement.c c For scale-up, countries can also set higher targets for any “First step” element to expand coverage of services and/or improve their quality.
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The essential elements in “First steps” are designated by numbers. The “Next steps” are indented, and each essential element is designated by a letter. Note that both first and next steps are considered essential elements as they are all WHO recommendations.
The elements in this checklist are abbreviated as short phrases. In Annex C, you will see a more detailed version called the MDR-TB Control Essential Elements Reference List, which includes citations to WHO recommendations, applicable global targets, and indicators for each element. Most of the indicators for the essential elements are based on data countries are already asked to report to WHO on the annual data collection form. Annex C also includes cross references since many essential elements are linked, or could be categorized under more than more component of the Stop TB strategy. Instructions for Checklist 3: Essentials Elements for MDR-TB Control Note: the checklist follows the instructions and sample checklist.
1. Starting with the first component of the Stop TB Strategy, fill out each row of the “First steps” with the following: If you already have national targets for any of the elements, write them in column 2. Otherwise, you can fill in global targets (where available) from the MDR-TB Control Essential Elements Reference List in Annex C. Complete column 3 (the country’s current performance) by using the most recent data available for your country. See most recent data published by WHO.17,18,20,27 Fill in the gaps (column 4) by subtracting current country performance (column 3) from the target (column 2). Check off any element where there is no performance gap (i.e., the target is already being achieved). 2. Now look at the “Next steps” for this component of the Stop TB Strategy. Circle any rows that you think this round of planning should address. For the “Next steps” you have circled, repeat the bulleted steps above. 3. Repeat steps 1 and 2 for each of the remaining components of the Stop TB Strategy.
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Essential Elements for MDR-TB Control Checklist—Sample In the sample checklist below, WHO targets have been filled in for two essential elements, as has data on the country’s current performance. By subtracting the current performance from the target, you can see which gaps remain. The first element has been achieved (shown by a checked or ticked box), so it may not need to be explored further. The second element shows a large gap and might be prioritized (using Tool 4).
1. Essential Elements 2. Target 3. Current 4. Gap (Target Performance Minus Current Performance) Lab capacity to detect isoniazid and rifampicin resistance 1 drug susceptibility 2 DST laboratories None testing (DST) in a country of 10 laboratory per 5 million population million population (2009) MDR-TB testing for all previously treated patients 100% of previously 10% had DST 90% treated patients have (2009) (900 patients) DST performed (100 patients) (1,000 patients)
Note: In the sample above, the first row is element “4” (“First step”) and the second row is element “a” (“Next step”), both under component 1B: Early case detection.
Version No. 2, February 2012 Tool 3: Analyze the current situation 21 Checklist 3: Essential Elements for MDR-TB Control Target Current Gap Performance
1. High-quality DOTS 1A. Political commitment with adequate, sustained financing First steps 1. MDR-TB scale-up plan and budget 2. Broad participation in planning process 3. Adequate financing and sustainability 4. Designated individuals responsible for MDR-TB scale-up 5. MDR-TB care free-of-charge
1B. Early case detection and diagnosis through quality-assured bacteriology First steps Detect MDR among TB cases: 1. MDR-TB testing in patients whose TB treatment is failing 2. Household contacts of MDR-TB patients screened for TB Adequate laboratory capacity and performance to: 3. Identify M. tuberculosis 4. Detect resistance to rifampicin and isoniazid 5. Laboratories report results as soon as available Laboratory network and infrastructure: 6. National Reference Laboratory (NRL) regularly quality-controlled by Supranational Reference Laboratory (SRL) 7. Specimen transport system 8. Biosafety
Next steps MDR-TB testing at start of treatment (or re-treatment) for: a. All previously treated cases b. New TB patients who are HIV positive c. Additional prioritized groups d. All new patients MDR-TB testing during treatment of: e. Previously treated patients who remain smear positive at month 3 of treatment f. New patients who remain smear positive at month 3 of treatment Other case-finding measures: g. Clinical follow-up of household contacts
Version No. 2, February 2012 Tool 3: Analyze the current situation 22 Checklist 3: Essential Elements for MDR-TB Control Target Current Gap Performance h. Detect fluoroquinolone and injectable resistance (extensively drug-resistant tuberculosis [XDR-TB]) i. Use of rapid tests to detect MDR-TB
1C. Standardized treatment with supervision and patient support First steps 1. National MDR-TB guidelines 2. Policy and procedures for enrollment into treatment 3. Confirmed MDR-TB cases start treatment 4. Initial evaluation, periodic monitoring for adverse effects 5. Management of side effects 6. Bacteriologic monitoring 7. Directly observed therapy 8. Ambulatory MDR-TB care (in the home or outpatient clinic) 9. Socioeconomic and psychological factors identified and addressed 10. Incentives and enablers 11. Prevent patient default 12. Referral system when patients are transferred 13. Expert committee provides consultation 14. Treatment of mono- or poly-drug resistance patterns
Next steps a. Policy on empiric MDR-TB regimensd b. Care of MDR-TB patients not receiving MDR-TB treatment c. Hospitalization available if acute level of care needed d. MDR-TB Center of Excellence e. Surgical interventions are available
1D. Effective drug supply and management 1. Second-line drugs (SLDs) meet WHO quality standards 2. Adequate supplies of SLDs at each level are available
Next steps a. Electronic drug management system
1E. Monitoring and evaluation (M&E), supervision First steps d For certain patients while awaiting confirmation of MDR-TB (if laboratory methods are not rapid).
Version No. 2, February 2012 Tool 3: Analyze the current situation 23 Checklist 3: Essential Elements for MDR-TB Control Target Current Gap Performance 1. WHO formats for recording and reporting MDR-TB cases 2. Data analyzed and used to improve programmatic management of drug-resistant tuberculosis (PMDT) 3. Systematic supervision and comparison of practice to guidelines 4. MDR-TB component in NTP’s M&E plan, external monitoring
Next steps a. Surveillance of drug resistance in previously treated patients b. Drug resistance survey (DRS) in the past 3 to 5 years c. Cross-checking laboratory and MDR-TB registers, data quality d. Analysis of HIV and MDR-TB concurrence e. Analysis of delays in treatment initiation, deaths while waiting f. Full drug-resistance patterns of a recent MDR-TB cohort g. Electronic case-based database
2. Address TB–HIV, MDR-TB, and the needs of poor and vulnerable populations 2A. TB–HIV activities First steps 1. MDR-TB patients know their HIV status 2. HIV-positive MDR-TB patients begin ART as soon as possible 3. HIV-positive MDR-TB patients begin cotrimoxazole 4. HIV-positive MDR-TB patients receive HIV care and support
Next steps a. HIV testing, counseling offered to suspected MDR-TB cases
2B. MDR-TB: These elements are distributed across the relevant Stop TB Strategy components.
2C. Address the needs of TB contacts and of poor and vulnerable populations First steps 1. Prisons linked to NTP for MDR-TB diagnosis, reporting, and care 2. MDR-TB diagnosis and treatment in other vulnerable populations
Version No. 2, February 2012 Tool 3: Analyze the current situation 24 Checklist 3: Essential Elements for MDR-TB Control Target Current Gap Performance
Next steps a. Assess equitable access to MDR-TB diagnosis and treatment
3. Contribute to health system strengthening 3A. Human resource (HR) development First steps 1. Focal person responsible for MDR-TB HR development 2. Assessment of HR requirements for MDR-TB services 3. Gaps in numbers of staff with requisite skills are defined 4. Plan for staffing, training, supervision, and support 5. Key staff in the needed categories are available 6. Key staff recently trained on drug-resistant TB
Next steps a. HR development plan for MDR-TB scale-up is monitored
3B. TB infection control (IC) First steps Implement managerial measures: 1. A national TB IC plan addresses settings where care is provided to patients with known or suspected MDR-TB 2. Facilities providing care to MDR-TB patients have IC assessment 3. In prioritye facilities, focal person develops and implements facility- specific IC plan Implement administrative controls: 4. Triage of patients with known or suspected infectious MDR-TB, cough etiquette, separation 5. If infectious MDR-TB patients hospitalized, airborne precautions 6. Health workers trained; HIV testing encouraged 7. TB diagnosed in health workers and data compiled
e Countries will prioritize settings depending on the findings of the risk assessments. Higher priority should be given to settings where TB is drug resistant, exposed people are especially vulnerable to developing disease if infected or dying if they develop TB (such as people living with HIV), exposure is of longer duration (due to diagnostic delays or inpatient care), control measures are lacking, or a large number of people are exposed. During the scale-up process, additional settings may be added to the priority list and additional infection control measures may be phased in.
Version No. 2, February 2012 Tool 3: Analyze the current situation 25 Checklist 3: Essential Elements for MDR-TB Control Target Current Gap Performance
Implement environmental controls: 8. Natural ventilation maximized where possible Implement respiratory protection programs: 9. Health workers use approved respirators when caring for patients known or suspected to have infectious MDR-TB
Next steps a. TB IC policy is part of the country’s overall IC policy b. National surveillance of TB disease among health workers c. Adequate ventilation of patient care areas in health facilities
4. Engage all providers First steps 1. Non-NTP providers linked to NTP for MDR-TB diagnosis, treatment
Next steps a. NTP captures source of MDR-TB patient referral b. Cohort analysis of MDR-TB patients treated outside the NTP c. Labs outside the NRL network report drug-resistance results
5. Empowerment of people with TB and communities First steps 1. MDR-TB patients provided high-quality patient-centered care 2. Community-based DOTS providers support MDR-TB patients
Next steps a. MDR-TB is included in the country’s ACSMf strategy
6. Research Next steps a. Research agenda includes MDR-TB b. Operational research results used to improve MDR-TB services
f Advocacy, communication, and social mobilization.
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Tool 4: Prioritize gaps
Once you’ve determined the gaps in the country’s current coverage of MDR-TB services using Checklist 3, you’ll need to prioritize them according to the country’s situation and to make best use of available resources. The Set Priorities worksheet will help you come to a consensus on the answer to this question:
Which are the most important gaps in MDR-TB control to address first?
When setting priorities, focus on the public health impact of the performance gap and the feasibility of addressing it. Instructions for Worksheet 4: Set Priorities 1. Column A of the worksheet: Refer to the checklist in Tool 3—enter the key words of any essential element that has not yet had its target reached (or been checked off). Label it with the number of the corresponding component of the Stop TB Strategy and the number or letter of the row from the checklist. 2. Column B: For each element, consider the public health impact of the gap. How big is the gap? How significant is the gap in terms of survival, quality of life, and community health? Assign the number 0 for the smallest impact, 1 for medium-sized impact, and 2 for greatest impact. 3. Column C: Consider the feasibility of the intervention. Is there an intervention that works? Will it be effective? Is the intervention feasible to implement? Is it a wise, efficient use of resources? (A good value for the money?) Is it the logical next step? Is there an agency, partner, or organization that can take responsibility for this activity? Assign the number 0 if the intervention is not feasible at all, 1 if it is possibly feasible, and 2 if it is very feasible. 4. Column D: Add up columns B and C. The rows with the highest numbers in column D are the highest priority gaps for the planning team to consider first. 5. Pull out the top-ranked 10 to 15 essential elements (the rows with the highest numbers in column D). Display them in order from highest to lowest public health impact and feasibility.
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6. Discuss and reach consensus about these questions: Does this ranking match the planning team’s judgment of highest priorities? Should any elements be combined or split? Should any elements be moved up or down the ranking? How many performance gaps do you want to address in this round of the planning process? Worksheet 4: Set Priorities A. Essential element B. Public health impact of C. Feasibility of D. Total (Add lines as needed) the gap intervention to address (B + C) 0: Small, not very significant the gap 1: Medium impact 0: Not feasible 2. Large, significant impact 1: Feasible 2: Very feasible
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Tool 5: Design activities to address priority gaps
Once you’ve decided which performance gaps are the highest priority to address, you can analyze them in more depth in order to design activities to address them. The worksheet in this tool will help you consider these questions:
Why do gaps in MDR-TB control exist? What are the biggest obstacles that lead to each gap? What should be done to overcome obstacles? What has the country achieved so far and how? Instructions for Worksheet 5: Understand the Gaps and Design Interventions Create a separate worksheet for each gap you have prioritized. (The worksheet is below, following the sample worksheet.) Fill in the boxes as follows:
Note: the numbers in these instructions correspond to the numbers in the boxes of the sample worksheet.
1. Enter the priority ranking # of the gap. 2. Enter the number and key words for the Stop TB Strategy component and the element from the MDR-TB Control Essential Elements Checklist. For example: Stop TB Strategy component: 1B. Early case detection and diagnosis. Essential element: 4. Adequate laboratory capacity to detect resistance to rifampicin and isoniazid. 3. Fill in the box labeled “Accomplished to date” by copying from column 3 from the Essential Elements for MDR-TB Control (Checklist 3). 4. Fill in the box labeled “Left to do” by copying from Checklist 3, Essential Elements for MDR-TB Control, column 4. 5. In the “Strengths” box, fill in what the country has accomplished so far to get to the current level of performance and describe what systems are already in place. 6. In the “Challenges” box, fill in the causes of the performance gap. List key obstacles to achieving the desired result. 7. Fill in Box 7 with activities that will help overcome each challenge as well as build on the country’s strengths or on opportunities that are presented. Activities should be feasible, locally appropriate, equitable, and based on evidence for effectiveness and sustainability.
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When you’ve finished the worksheets, you will have designed interventions to address each of your priority gaps. Review the worksheets together to identify areas of overlap, common themes, and missing activities.
Note: For some gaps, countries may elect to perform a more in-depth analyses using such methods as the “Cough to cure pathway”,28 the “Onion” model for TB case detection and notification,29 or methods such as the “Why Tree” or “Fishbone diagram”,30 root cause analysis,31 or operational research (such as causes of laboratory delays).32
Example from Tool 3. 1. Rank # 1 2. Stop TB Strategy component: 1B. Early case detection and diagnosis Essential element: a. MDR-TB testing for all previously treated patients 7. Activities to address performance gap 3. Accomplished to date 4. Left to do (gap) By 2012, the NTP will help 5 targeted districts Among the 1,000 notifications of 900 previously treated patients did outside the capital determine barriers to MDR-TB previously treated patients in 2009, not have MDR-TB testing. testing of previously treated patients. They will 10% (100) had MDR-TB testing at write into their district plans the steps needed to the start of re-treatment. ensure sputum specimens from 80% of previously treated patients are collected at the start of re- 5. Strengths 6. Challenges treatment and sent to the laboratory. In the capital city, the districts have Outside the capital city, district TB a system in place to trace each coordinators do not routinely follow By 2013, the NTP will contract with a national registered re-treatment case and up to ensure each previously treated courier agency to transport sputum specimens follow up with the health center patient that is registered has from districts outside the capital. staff to ensure specimens are sent specimens sent for MDR-TB testing. for culture and DST and that results are received and acted upon. There is no courier system and the only laboratory performing culture A courier system between health and DST is in the capital city. centers means the patient doesn’t have to travel far to provide a specimen.
Make copies of this blank worksheet (below) so you have a separate worksheet to fill out for each of your prioritized gaps.
Version No. 2, February 2012 Tool 5: Design activities to address priority gaps 30 The MDR-TB Planning Toolkit
Worksheet 5: Understand the Gaps and Design Interventions Rank # Stop TB Strategy component: Essential element: Activities to address performance gap Accomplished to date Left to do (gap)
Strengths Challenges
Version No. 2, February 2012 Tool 5: Design activities to address priority gaps 31 The MDR-TB Planning Toolkit
Tool 6: Finalize goal, objectives, and targets
Now that you have designed activities to address your highest priority performance gaps, it is time to determine if they will be sufficient to reach the preliminary targets you set with Tool 2. Then you can finalize objectives, set yearly targets, and create a plan to monitor activities to ensure they are successfully achieving objectives and contributing to your goal.
There are three worksheets in this tool: (6A) Final Results Framework, (6B) Final Goal and Objectives, and (6C) Interim Targets During the Life of the Plan. They will help you answer these questions:
Will planned activities lead to desired results? How will results be measured? How much will be accomplished each year?
These worksheets focus on the outcome and output objectives used in Tool 2. Your country may choose to add more output and outcome objectives depending on your situation and priorities. Instructions for Worksheet 6A: Final Results Framework Use the worksheet (that follows these instructions) to finalize your Results Framework and check that the planned activities will indeed lead to the desired outputs, outcomes, and impact. This will also help you monitor the implementation of the MDR-TB plan.
A. Copy the output and outcome targets you set in your Preliminary Results Framework (Worksheet 2). Show the baselines for comparison.
B. Fill in the main activities you designed in Tool 5. In the top half of the activities column, list the activities that will contribute to MDR-TB testing. In the bottom half, list the activities that will help your country enroll MDR-TB cases into treatment.
Some activities will contribute to both MDR-TB case finding and treatment. You could choose whether the activity is more likely to impact (or more directly impacts) MDR-TB case finding or MDR-TB treatment. Alternatively, you could choose to display cross-cutting activities in a new row along the bottom.
An example would be engaging providers outside the NTP (Stop TB Strategy component #4). Public/private mix activities can be considered “cross cutting” if they engage providers to both detect and treat TB. Perhaps in your country, the main role you want these providers to play is to recognize a suspected case of MDR-TB and refer the patient for drug susceptibility testing. Then you would place your public/private mix activities in the causal chain they are most likely to impact, which is the top half of the Results Framework. Alternatively, if the providers were going to both detect and treat TB, you could display this cross-cutting activity in a new row along the bottom of your framework.
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C. Now stop and look at the Final Results Framework to check the causal links (from activities to outputs to outcomes to impact):
Will the activities in the top half of the framework lead to improved MDR-TB case finding? If fully funded and implemented, will they be sufficient for achieving your targets for DST and MDR-TB case detection? Revise the activities, outputs, and outcomes accordingly.
Repeat for the bottom half of the Final Results Framework for improving access to MDR-TB treatment. Worksheet 6A: Final Results Framework 4. Activities 3. Outputs 2. Outcomes 1. Impact 3.1. Previously treated 2.1. MDR-TB cases patients with MDR-TB tests detected
Baseline: __ (year) Baseline: __ (year) Target: __ (final year of Target: __* (final year of plan) plan) Decreased 3.2. MDR-TB patients 2.2. MDR-TB cases burden of g starting treatment successfully treated MDR-TB
Baseline: __ (year) Baseline: __ (year) Target: __* (final year of Target: __ (final year of plan) plan) *Since all confirmed MDR-TB cases need to be treated, these targets should be the same number of MDR-TB patients.
g NTPs usually think of this indicator as a percent, rather than an absolute number. Per Tool 2, you can insert a percentage for this baseline and the target. Also, NTPs may prefer to use an interim indicator, such as percent with negative cultures, died, or defaulted at month six of treatment. (See Annex C, Section 1C).
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Overview of Worksheet 6B: Final Goal and Objectives This worksheet will help you translate the targets you just finalized into the language of formal goals and objectives so they are ready to insert into your plan.
Goal: Goals are often long-term impacts that are not easily realized in a short-term plan of only a few years. Sometimes, goals may be more aspirational, since they may be difficult to measure, particularly in the short-term. Up until now, this toolkit has used “Decreased burden of MDR-TB” as the goal. It would be preferable to have a more specific goal for the MDR-TB plans you are developing. The challenge, therefore, is how to make this goal measurable. The instructions for Worksheet 6B (below) describe one way to meet this challenge.
Objectives: The last column of Worksheet 6B contains language you can use to turn each target from Worksheet 6A into an objective that is SMART:
Specific Measurable Achievable Relevant Timebound (i.e., by specifying a due date)
The objectives use standard indicators from the Global Plan15 to allow you to measure your country’s performance. On its annual data collection form, WHO asks countries to report all the outcome and output indicators listed in Worksheet 6B. Citations for each indicator appear in column 2 of the MDR-TB Control Essential Elements Reference List in Annex C.
In Worksheet 6A, most of the targets for your outcomes and outputs were expressed as numbers of patients (such as MDR-TB patients to detect). The instructions to Worksheet 6B walk you through the steps necessary to translate those numbers into the percent of patients needing to be served. In this way, you will be able to assess the progress your country is making toward universal access to MDR-TB testing and treatment. Beyond “access” to services, “coverage” refers to the percent of the target population that actually benefits from the intervention.33 Instructions for Worksheet 6B: Final Goal and Objectives A. Goal.
A 3- or 5-year plan may be too short a time frame in which to measure the epidemiologic impact of your activities on the burden of MDR-TB. Furthermore, quantifying the ultimate desired impact of MDR-TB control is challenging. For grant performance (i.e., the Global Fund), WHO recommends that countries select indicators they can directly measure.34 The Global Plan15 proposes using
Version No. 2, February 2012 Tool 6: Finalize goal, objectives, and targets 34 The MDR-TB Planning Toolkit
declining MDR-TB incidence as an impact indicator. However, most countries cannot directly measure this indicator, and WHO provides these estimates only periodically.22
An alternative measure of impact is the percent of new patients with multidrug resistance. This indicator is directly measurable by countries that conduct population-based drug-resistance surveys.35 The occurrence of MDR-TB in a new TB patient is a warning sign that there has been an infectious MDR-TB case in the community. The larger the number of untreated MDR-TB cases in the community, the more infectious sources for spreading MDR-TB, and the more people who will become ill with MDR-TB. For this reason, the percent of new patients with multidrug resistance can be considered a long-term measure of the burden of MDR-TB in a country.2
If you choose to use this measure, fill in the baseline percent of new TB patients with MDR-TB from the most recent drug-resistance survey or model. (WHO posts these online for every country.17) Determine how much you aim to lower this percent to reach the target (Box 1.1) for the final year of your plan. To assess impact at the end of your plan, you would need to have continuous surveillance of MDR-TB in new TB patients or conduct another drug-resistance survey.
B. Outcome and output objectives and baselines.
To fill in the baselines for 2.1, 3.1, and 3.2, find the baseline numbers of patients served from Worksheet 6A, and insert them into the corresponding blanks in column 2 of Worksheet 6B designated by the # symbol. To complete Objectives 2.1, 3.1, and 3.2, find the target numbers of patients to serve from Worksheet 6A, and insert them into the blanks in column 3 of Worksheet 6B designated by the # symbol. To complete Objective 2.2 and its baseline value, copy the target and baseline percent of patients successfully treated from Worksheet 6A. To calculate percentages for the remaining objective and baselines, you’ll need denominators (indicated as gray blanks in Worksheet 6B), which are the number of patients needing the service. Below are suggested sources for each denominator and the final steps to complete this worksheet. C. Outcome objectives and baselines—percentages.
2.1. MDR-TB case detection. WHO publishes the percent of MDR-TB cases found among new and re-treatment cases tested in the country’s most recent drug-resistance survey (or model).17 WHO applies these percentages to the country’s new pulmonary and all re-treatment notifications to develop an estimated number of MDR-TB cases that could be detected if all these notified cases were tested.17 Look up this WHO estimate in your country’s profile at this website: http://www.who.int/tb/country/data/profiles/en/index.html.
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Fill in the gray shaded blank (____) in 2.1 with this WHO estimate, which is your denominator.h To express Objective 2.1 as a percent of estimated MDR-TB patients, divide the numerator (___#) by the gray-shaded denominator (____). Fill in the results in the ___% space. To express the baseline as a percent of the estimated MDR-TB patients, divide the baseline number of detected MDR-TB cases by the WHO estimate for that year.17 2.2. MDR-TB treatment. This is already expressed as a percent in Worksheet 2 and Worksheet 6B. D. Output objectives and baselines—percentages.
3.1. MDR-TB testing. Fill in the gray shaded blank (____) with the number of previously treated patients notified in the most recent year for which you have data available.i WHO publishes this in the same website given above.17 To express Objective 3.1 as a percent of the previously treated patients notified that year, divide the numerator (___#) by the gray-shaded denominator (____). Fill in the results in the ___% space. To express the baseline as a percent, divide the number of previously treated patients tested in the baseline year by the number of previously treated notifications that year.20 3.2. MDR-TB patients starting treatment. Fill in the gray shaded blank (____*) with the number of MDR-TB cases you plan to detect in the final year of the plan, since all will need to be enrolled in treatment. Objective 3.2 should be 100%, since all detected MDR-TB cases should be offered treatment. To express the baseline as a percent, divide the number of MDR-TB cases enrolled in treatment in the baseline year by the number of MDR-TB cases confirmed that year.20
h It is difficult to estimate the number of MDR-TB cases among future notifications. For simplification, you can use the most recent estimates WHO has published.17 i It is difficult to estimate the number of previously treated cases that will be notified in the future (the final year of the plan). For simplification, you can assume the same number of re-treatment notifications in the final year of your plan as in your most recent year.
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Worksheet 6B: Final Goal and Objectives 1. Impact indicator Baseline (20xx) Goal New TB patients with ___% 1.1. In the final year of this plan (20xx), ___% of new TB patients will be found to MDR-TB have multidrug resistance.
2. Outcome indicators Baseline (20xx) Outcome Objectives ___(#) 2.1. In the final year of this plan (20xx), ___* (#) of MDR-TB cases will be detected. MDR-TB cases detected This is ___% of the ____ estimated MDR-TB cases among TB notifications that ___% year. MDR-TB cases 2.3. In the cohort starting treatment in the final year of this plan (20xx), ___% of successfully treated ___% MDR-TB cases will be successfully treated.
3. Output indicators Baseline (20xx) Output Objectives 3.1. In the final year of this plan (20xx), ___ (#) of previously treated TB patients Patients tested for MDR- have MDR-TB testing at the start of re-treatment. TB ___% This is __% of the ____previously treated notifications expected for that year.j 3.3. In the final year of this plan (20xx), __* (#) of confirmed MDR-TB cases will start MDR-TB patients starting ____(#) on MDR treatment. treatment This is 100% of the ____* MDR-TB cases that will be detected in that year. ____%
Notes:
The two spaces designated with * should be filled in with the same number of MDR-TB patients, since all diagnosed MDR-TB patients need to be started on treatment
The numbers in the last column correspond to the boxes in Worksheet 2 and 6A and the numbers in the instructions above.
The denominators for calculating percentages are designated by gray shaded blanks (____).
You will need to replace 20xx with the correct years (i.e., 2015).
j It is difficult to estimate the number of previously treated cases that will be notified in the future (the final year of the plan). For simplification, you could assume the same number of re-treatment notifications in the final year of your plan as in your most recent year.
Version No. 2, February 2012 Tool 6: Finalize goal, objectives, and targets 37 The MDR-TB Planning Toolkit
Instructions for Worksheet 6C: Interim Targets During the Life of the Plan
Now that you’ve set the final targets for your MDR-TB plan, you can set interim targets for each year leading up to the final year. (Later, some implementing agencies may want to set even shorter-term targets, such as for a quarterly work plan.)
1. Display the years your plan encompasses in the table below. To do this, replace “20xx” with the actual years of your plan. (See the example below of a 5-year plan.) 2. Refer to the objectives you set in Worksheet 6B for outcomes and outputs. List each of these under objectives. (Add rows as needed.) 3. For each objective, look at the timing of the planned activities to determine how much can be accomplished each year in order to reach the final year’s target.
Example: A planning team reviewed the activities planned for laboratory scale-up and determined it was feasible to increase testing of previously treated TB patients in order to improve MDR-TB case detection. The team set its targets as:
Output objective Baseline Targets Value Year Data source 2012 2013 2014 2015 2016 By 2016, 80% of previously treated 100 tested of 1000 2009 TB 150 250 400 700 800 patients notified each year have previously treated notifications, (15%) (25%) (40%) (70%) (80%) MDR-TB testing at the start of re- notifications= 10% laboratory treatment. data
Worksheet 6C: Interim Targets During the Life of the Plan Objective Baseline Targets Value Year Data source Year Year Year Year Year 20xx 20xx 20xx 20xx 20xx
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Tool 7: Budget and assemble the plan
Once you’re confident your planned activities will achieve your desired objectives, it’s time to secure commitments for implementation. Unless specific organizations take responsibility and resources are secured, a plan cannot be implemented. Consider the following questions:
Who will take responsibility for implementing which activities? How much will it cost to implement each activity? Where will the resources come from?
The Activities, Budget, and Implementers worksheet will help you develop the budget and secure commitments for activities and resources. At the end of Tool 7, you will also find suggestions for assembling your plan. Instructions for Worksheet 7: Activities, Budget, and Implementers Worksheet A. Activities: In column A of Worksheet 7 (below), record each activity from Worksheet 6A, column 4. You may want to group them by Stop TB Strategy component or by national plan component. Add rows as needed. B. Implementer: Propose an agency or organization to take lead responsibility for implementing each activity. C. Total cost: Determine the projected cost of each activity over all years of the plan and record the total on the spreadsheet. The projected cost can be calculated using the WHO Planning and Budgeting tool.36 D. Available resources: Fill in the funding available for each activity in the current year and estimate the funding that will be available for the remaining years of the plan. This requires that the NTP and partners inventory what they are already contributing and what they are planning to contribute over the term of the plan. E. Financial gap: Subtract D (available resources) from C (total cost) to estimate the financial gap for each activity. The gap can also be summed across Stop TB Strategy components and the plan as a whole. F. Possible funding sources to fill the gap: Write in the names of possible sources of new funding to fill the financial gap and estimated contributions from each of the sources. You can secure commitments from each of the implementers and finalize your budget using the steps you listed in Worksheet 1B (Task Timeline) in Tool 1.
Version No. 2, February 2012 Tool 7: Budget and assemble the plan 39 The MDR-TB Planning Toolkit
Worksheet 7: Activities, Budget, and Implementers Worksheet Note: The lettered columns correspond to the worksheet instructions above. A B C D E F
Activity Implementer Total Available Financial gap Possible funding costk resources (C–D) sources to fill gap
See also WHO Planning and Budgeting tool.36 Assemble your plan As you assemble your plan, check that important performance gaps are well described, the activities address the gaps, and the budget is aligned to focus on priority gaps. As the resource picture becomes clearer, you may need to revise activities and targets. Here is a sample outline for organizing your MDR-TB plan.1 See also Annex B for options for where to place MDR-TB elements within a national stop TB plan. Sample Plan Outline 1. Introduction (See Tool 1). Rationale for the plan. Time frame the plan covers. How this plan relates to the country’s health sector plan and other relevant plans (for example, HIV/AIDS, laboratory strengthening, human resource development). Describe the process used to develop the plan. How were stakeholders involved? 2. Goals and objectives (See Tool 2, 6). 3. Situation assessment (See Tool 3, 4, 5).
k Over all years of the plan.
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4. Activities, responsible organization. Tie activities to output and outcome objectives (See Tool 5, 6). Determine the organization responsible for each activity (See Tool 7). 5. Budget (See Tool 7) 6. Monitoring (See Tool 6).*
*Monitoring MDR-TB scale-up should be part of your country’s overall monitoring and evaluation plan and consistent with the applicable regional MDR-TB response plan.2–4,6,7 Guidance is available from the Global Fund and WHO for developing such a plan.10–13,19 See also indicators and citations listed for each element in column 2 of the MDR-TB Control Essential Elements Reference List (Annex C).
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Tool 8: Review the plan
This tool is designed to help you assess the MDR-TB control component of your national TB plan. It can be used for an already existing MDR-TB component as well as for one developed using this toolkit. This tool can be used by the NTP, stakeholders, or independent parties to answer these questions:
Does the MDR-TB control component of the national TB plan contain the “key ingredients” of a sound plan? What are the strengths and weaknesses of the MDR-TB control component? What changes are needed in the plan for successful implementation? Overview of Tool 8: Assess the MDR-TB Component of a National TB Control Plan Tool 8 contains six ingredients considered the foundation of any robust national plan.1 They are:
1. Planning process: inclusive process is used to develop the plan; high-level commitment. 2. Situation analysis: comprehensive analysis covers the context and health sector responses. 3. Programming: priorities, objectives, and activities are clear and relevant. 4. Finance: costs and budgetary framework are sound and feasible. 5. Implementation and management: institutional capacity and systems are in place. 6. Results monitoring and review: monitoring mechanisms are sound and results are used for decision-making and action.
These are ingredients that ideally would be present for a plan to be considered technically sound. If your plan is still some distance from achieving these ideals, the plan can indicate how the country will make progress toward achieving them.1
Each of the six “key ingredients” of a sound plan has several characteristics. By checking your MDR-TB component against these characteristics, you can identify parts of your plan that may need to be strengthened or updated. Tool 8 refers you to other relevant tools within this toolkit that you can use to address any weak areas. For example, if Tool 8 reveals gaps in your plan’s situation analysis, you are referred to the checklist in Tool 3 to revisit this “key ingredient.”
Assessment of the MDR-TB component requires a review of additional documents, such as the overall TB strategy, the national health sector plan, and the country’s TB monitoring and evaluation plan. To help you assess each of the characteristics in Tool 8, reference 1 lists additional guidance on what documents to use, what to look for, and “warning signs” that may indicate weaknesses in how the characteristic is addressed in the plan.
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Note about “Plan” versus “Strategy” Tool 8 (and the rest of this toolkit) are intended to assist countries in scaling up the diagnosis and treatment of MDR-TB, which requires detailed planning. The International Health Partnership (IHP+)1 defines a Plan as a document, or set of documents, that provides details of how objectives are to be achieved, time frame for work, who is responsible, and how much it will cost. This may be in the form of a multi- year plan, supported by annual operational plans. (This is in contrast to a Strategy, which IHP+ defines as providing the big picture: the context, vision, priorities, objectives, and key interventions to inform more detailed planning documents.) Instructions for Worksheet 8: Assess the MDR-TB Component of a National TB Control Plan For each of the six “key ingredients” of a sound plan:
1. Check all boxes that apply.
2. Summarize the strengths and weaknesses of this ingredient and their implications for successful implementation of the plan. Then list changes needed to enhance the quality of the plan.
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Worksheet 8: Assess the MDR-TB Component of a National TB Control Plan Country: Plan name: Date finalized:
1. PLANNING PROCESS: inclusive process is used to develop the plan; high-level commitment
1.1. National TB program (NTP) led the development of the plan.
1.2. A transparent mechanism ensured meaningful participation of all stakeholders.
1.3. The plan was (or will be) formally endorsed at a high level in government.
1.4. Political commitment is shown by maintaining or preferably increasing government’s financing of the MDR-TB component.
For further guidance on what to look for to assess this key ingredient, where to look, and warning signs, see characteristics 2.1, 2.4, 2.5 of reference 1.
Assessment of key ingredient 1: Planning Process Strengths Weaknesses Implications for successful implementation Changes needed in the plan [See Tool 1]
2. SITUATION ANALYSIS: comprehensive analysis covers the context and health sector responses
2.1. The plan describes the most recent WHO estimates of TB burden, including:
□ Estimated TB incidence (number and rate). □ Estimated TB incidence in HIV-positive patients (number and rate). □ Estimated Number of MDR-TB cases among new pulmonary TB cases. □ Estimated Number of MDR-TB cases among re-treatment TB cases. (See Worksheet 6B and ref 17.)
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2.2. The plan includes an analysis of the most recent available country reports17 on the key MDR-TB indicators in the Global Plan15:
□ Number and proportion of new and previously treated TB patients with DST. □ Number of confirmed MDR-TB cases in new TB case notifications, proportion of estimate in 2.1 above. □ Number of confirmed MDR-TB cases in re-treatment notifications, proportion of estimate in 2.1 above. □ Number and proportion of confirmed MDR-TB patients enrolled in WHO-endorsed treatment protocols. □ Treatment outcomes of MDR-TB cohort. (See Worksheet 6B.)
2.3. The plan includes a comprehensive analysis of the current MDR-TB situation, covering the following areas (within and outside the NTP):
□ Political and financial commitment. □ Available infrastructure (from both MOH public health and non-NTP sources, including the private sector). □ MDR-TB case-finding strategy. □ Laboratory diagnosis and follow-up of MDR-TB. □ MDR-TB treatment strategy, including regimen and model of care, side effects and follow-up management, treatment delivery (DOTS), adherence and social support. □ Second-line drug procurement and supply management. □ Management and supervision of the program (including partnership and involvement with other stakeholders). □ Public-public and public-private mix. □ Human resource development: program staffing, training, and technical assistance strategy. □ Infection control. □ Monitoring and evaluation (M&E) (including recording and reporting system). □ HIV and high-risk groups (including MDR care for prisoners and migrants). □ Operational research. (See Tool 3.)
2.4. Target performance is identified and gaps are quantified (target minus current performance.) (See Tools 2, 3, 6.)
□ Monitors progress toward achieving the latest MDR-TB monitoring mission recommendations. □ Monitors progress toward achieving Global Plan 2011–2015 targets.15
2.5. Gaps are prioritized. (See Tool 4.)
2.6. SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis has been carried out (optional). (See Tool 5.)
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2.7. Strategies are planned to mitigate obstacles to successful implementation. (See Tool 5.)
For further guidance on what to look for to assess this key ingredient, where to look, and warning signs, see characteristics 1.1-1.3, 1.6, 1.9, of reference 1.
Assessment of key ingredient 2: Situation Analysis Strengths Weaknesses Implications for successful implementation Changes needed in the plan
3. PROGRAMMING: priorities, objectives, and activities are clear and relevant
3.1. MDR-TB component is consistent with the country’s overall TB strategy and other health sector plans. (See Tool 1.)
3.2. In decentralized health systems, there is an effective mechanism to ensure sub-national plans address national-level goals and targets. (See Tool 1.)
3.3. The MDR-TB component describes scaling up diagnosis and treatment of MDR-TB including timeline. (See Tools 2, 5, 6.)
3.4. Each objective: □ Is clearly defined. □ Is SMART (specific, measurable, achievable, relevant, and timebound). □ Addresses the priority gaps. □ Clearly states the population target. (See Tool 6.)
3.5. Each objective includes: □ Background and rationale. □ Activities. □ Expected result (output or outcome indicator and target). (See Worksheet 6A and Tool 7.)
3.6. Each planned activity (intervention) is:
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□ Feasible. □ Locally appropriate. □ Equitable. □ Based on evidence and good practice. □ Based on considerations of effectiveness and sustainability. □ Clearly specified. □ Contributing to at least one objective. (See Tools 2, 5, 6, 7.)
For further guidance on what to look for to assess this key ingredient, where to look, and warning signs, see characteristics 1.4-1.6, 2.6, 2.7, 4.2 of reference 1.
Assessment of key ingredient 3: Programming Strengths Weaknesses Implications for successful implementation Changes needed in the plan
4. FINANCE: costs and budgetary framework are sound and feasible
4.1. Financial management system and process leading to MDR-TB budget approval is described.
4.2. A description is given for how the plan for TB control and its MDR component integrates with the national planning cycle. You may consult the WHO Country Planning Cycle Database at http://www.internationalhealthpartnership.net/en/about/j_1253621551.
4.3. Estimated funding needs for each objective and activity are included for each year of the plan.
4.4. Available funding per activity is broken down by sources, and the funding gap is specified.
4.5. Lead and partner implementation agencies are stated for each budgeted activity.
4.6. Internal and external funds channeling, management, and reporting mechanisms are described.
4.7. WHO Planning and Budgeting tool reports are used (optional).36
For further guidance on what to look for to assess this key ingredient, where to look, and warning signs, see characteristics 3.1-3.5 of reference 1.
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Assessment of key ingredient 4: Finance Strengths Weaknesses Implications for successful implementation Changes needed in the plan [See Tool 7]
5. IMPLEMENTATION AND MANAGEMENT: institutional capacity and systems are in place
5.1. Annual operational plans translate multi-year objectives into actions and describe the roles and responsibilities of implementing partners.
5.2. Plan is updated regularly.
5.3. Human resource needs are identified, including staffing levels, skills mix, distribution, training, supervision, pay, and incentives.
5.4. Logistics, information, and management system constraints are described, and actions are proposed to resolve the constraints.
5.5. Systems and capacity for planning, budgeting, and technical and managerial supervision are in place and properly resourced.
5.6. Technical-assistance needs are defined37; activities are specified and budgeted for strengthening national capacity.
5.7. Decision-making, oversight, coordination, and reporting mechanisms are described for plan implementation.
For further guidance on what to look for to assess this key ingredient, where to look, and warning signs, see characteristics 4.1, 4.5-4.8, 4.13 of reference 1.
Assessment of key ingredient 5: Implementation and Management Strengths Weaknesses Implications for successful implementation Changes needed [see Tools 1 and 7]
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6. RESULTS MONITORING AND REVIEW: monitoring mechanisms are timely and accurate, and results are used for decision-making and action 6.1. An M&E framework reflects the goals and objectives of the MDR-TB plan and budget, and feeds into the national TB plan’s M&E framework.
6.2. Partners agree to use and contribute to one M&E framework, and report to the NTP.
6.3. The M&E framework includes clearly defined:
□ Impact indicators (for the overall goals). □ Outcome and output indicators for the objectives, consistent with the MDR indicators in the Global Plan15 (listed in 2.2 of this tool). □ Realistic targets for each indicator. □ Annual milestones that can be used to measure progress and make performance-based decisions. □ Data sources and collection methods. □ Information flows.
6.4. Data are analyzed and translated into information for decision-making and are regularly disseminated.
6.5. Supportive supervision to sub-national levels gives feedback to improve performance.
6.6. A multi-partner review mechanism regularly assesses program performance against targets.
6.7. Gaps and weaknesses are identified in M&E systems, and actions to strengthen capacity are planned and budgeted.
For further guidance on what to look for to assess this key ingredient, where to look, and warning signs, see characteristics 5.1-5.9 of reference 1.
Assessment of key ingredient 6: Results Monitoring and Review Strengths Weaknesses Implications for successful implementation Changes needed [See Tool 6]
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Annexes
Annex A. Acronyms and abbreviations.
ACSM advocacy, communication, and social mobilization ART antiretroviral therapy DOTS directly observed therapy, short-course DRS drug resistance survey DST drug susceptibility testing Global Fund The Global Fund to Fight AIDS, Tuberculosis and Malaria HR human resource IC infection control M&E monitoring and evaluation MDR-TB multidrug-resistant tuberculosis MOH ministry of health NRL national reference laboratory NTP national TB program PATH Program for Appropriate Technology in Health SLD second-line drugs SRL supranational reference laboratory TB tuberculosis USAID United States Agency for International Development WHO World Health Organization XDR-TB extensively drug-resistant tuberculosis
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Annex B. Options for where to place MDR-TB activities within a national stop TB plan
Sample Plan Outline (Supplement to Tool 7) 1. Introduction 2. Goals, objectives 3. Situation assessment 4. Activities
Stop TB Strategy components Option A Option B 1. DOTS Basic DOTS (first describe activities for 1A. Political commitment basic DOTS, then for MDR-TB). MDR-TB elements Basic DOTS only 1B. Detect “ “ 1C. Treat “ “ 1D. Drug supply “ “ 1E. Monitoring and evaluation “ “ 2A. HIV “ “ 2B. MDR-TB None, write “MDR-TB elements distributed Put all MDR-TB elements here, organized under under Stop TB Strategy components.” headings of all six Stop TB Strategy components. 2C. Poor, vulnerable Basic DOTS Basic DOTS only MDR-TB elements 3. Health systems strengthening “ 3A. Human resources “ 3B. Infection control “ “ 4. Engage providers “ “ 5. Empower “ “ 6. Research “ “
Pros of this option Easier to integrate into NTP plan. Easier to pull out MDR-TB elements. Least redundancy. Cons of this option Harder to pull out MDR-TB elements (for Harder to integrate, more duplication. budgeting, program review, etc.).
5. Budget 6. Monitoring and evaluation
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Annex C. MDR-TB Control Essential Elements Reference List (Supplement to Checklist 3) This checklist consists of all relevant WHO recommendations essential for scaling up the detection and treatment of MDR-TB. Each row of the first column is one of the essential elements. More detailed descriptions are provided here than in Checklist 3. Each element includes the citation to the WHO recommendation, so the reader can see the full context of each WHO recommendation and the evidence base used to develop the recommendation. All the references (with web links) are listed in Annex D. The “First steps” elements are numbered, followed by “Next steps,” which are labelled with letters.
Column 2 contains published global targets for many of the essential elements, their citations, and references to available published data for each country. For ease of use, most of the indicators for the essential elements are based on data that countries are already asked to report to WHO on the annual data collection form.
Essential Elements Target 1. Pursue high-quality DOTS expansion and enhancement 1A. Secure political commitment with adequate, sustained financing [See also M&E in component 1E, advocacy in component 5] First steps 1. Country has a current national TB plan approved by the government that includes an Yesl assessment, plan, and budget for scaling up the detection and treatment of MDR-TB.14,16,38 2. Representatives from civil-society organizations, people living with HIV/AIDS or affected by Yes TB, and health care providers outside the NTP participate in MDR-TB planning.38 3. The budget for the MDR-TB expansion plan is adequately financed and sustainable.16,38 ___% gap17 ___% of MDR-TB budget funded ___% funded by domestic sources
4. An individual at each level of the national TB program (NTP) (central, regional, and local) is Yes designated to be responsible for planning and implementing MDR-TB scale-up.38 5. Diagnosis and care of MDR-TB is provided free of charge to patients, including ancillary Yes tests and medications needed to monitor and manage the patient’s TB and any adverse TB treatment events.38–40 1B. Ensure early case detection and diagnosis through quality assured bacteriology [See also training in component 3B] First steps Detect MDR-TB among TB cases (outcome indicator in worksheets 2, 6A, 6B) > 50% of estimatedm MDR-TB cases are reported15 __% in new cases __% in previously treated cases 1. Drug susceptibility testing (DST) is performed on specimens obtained when TB treatment is 100% of failure patients have DST performed
l “Yes” indicates the element is in place. m The Global Plan15 uses the term “expected.” By contrast, the most recent WHO report20 and country profiles17 use estimated MDR-TB cases among TB notifications (new pulmonary and re-treatment cases).
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Essential Elements Target determined to be failing in any TB patient.21,35,41 # of patients with MDR-TB testing as a __% of those failing first course n # of patients with MDR-TB testing as a __% of those failing subsequent courses19 2. Household contacts of MDR-TB cases are evaluated to find additional TB cases. (If TB Yes cases are found, DST is obtained).21,38,41 Adequate laboratory capacity and performance 3. Laboratory capacity to identify M. tuberculosis meets national needs, and laboratories >1 culture lab per 5 million population15 demonstrate acceptable performance.11,21,41,42 4. Laboratory capacity for detecting resistance to rifampicin and isoniazid meets national At least one DST lab per 5 million population20 needs, and laboratories demonstrate acceptable performance.11,14,16,38,43,44 >95% agreement for isoniazid and rifampicin between the SRL and the NRL35 __ (#) of DST units for which external quality assurance was carried out 5. Laboratories performing testing for MDR-TB report to the treatment center as soon as NRL implemented a quality management system results are available.38 according to international standards15 Laboratory network and infrastructure 6. The country has a national reference laboratory (NRL) that is regularly quality-controlled by NRL implemented a quality management system a supranational reference laboratory (SRL).11,35,38 according to international standards15 7. A system of collecting and transferring specimens and cultures from the patient to the Yes appropriate laboratory is rapid, reliable, and safe.38,44 8. Biosafety procedures are in place in laboratories identifying M. tuberculosis or performing Yes DST.38,45 (Appropriate biosafety measures are in place in NRL15) Next steps MDR-TB testing at start of treatment (or re-treatment) a. DST is performed on specimens obtained at start of re-treatment for all previously treated 100% of previously treated cases are tested for drug cases (whether their current treatment has failed or they are returning after relapse or default resistance15,17–20 (output indicator in worksheets 2, 6A, 6B).21,35,40,41 b. DST is obtained at the start of TB treatment for new TB patients who are HIV 100% of new HIV-positive TB patients tested for drug positive.21,38,40,41,46 resistance at the start of TB treatment17,19,21 c. Country identifies additional groups of TB patients with high levels of multidrug resistance to ___% TB cases with DST result by each risk category19 prioritize for DST at start of treatment.21,38 d. DST is obtained at the start of treatment for all new patients.21,23,40 20% of new TB cases are tested for drug resistance15,17,18,20 MDR-TB testing during treatment e. Culture and DST are performed on specimens from previously treated patients who remain Yes smear positive at month 3 of treatment.21,41
n Formerly called “failures of Category 1.”
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Essential Elements Target f. Culture and DST are performed on specimens from new patients who remain smear positive Yes at month 3 of treatment.21,41 Other case finding measures g. Close contactso of MDR-TB patients receive careful clinical follow-up for at least two years.38 Yes h. If resistance is detected to rifampicin, then susceptibility testing is performed for isoniazid > 90% of confirmed cases of MDR-TB have a DST result and other first-line drugs, as well as the fluoroquinolones and second-line injectable agents for fluoroquinolones and a second-line injectable drug15,19 most often used in the country.35 i. Rapid tests to detect MDR-TB are available.16,21,38,45 Specifically, Xpert MTB/RIF is used as > 90% of tests for drug resistance performed on the initial diagnostic test in individuals suspected of MDR-TB.40,46,47 previously treated cases are done using rapid tests (> 50% in new cases)15 1C. Provide standardized treatment with supervision and patient support [See also training in component 3A] First steps Successfully treat drug-resistant TB (outcome indicators in worksheets 2, 6A, 6B) Outcomes >75% of patients with confirmed MDR-TB are successfully treated11,15,18,19 __% of each: cured, completed, died, failed, defaulted, no outcome18 Interim results __% of MDR-TB cases registered and started on MDR- TB treatment who have negative culture results during month 6 11,19 __% died by month 6 __% defaulted by month 6 1. The national MDR-TB guidelines (including MDR-TB regimens and criteria to change from Yes the intensive to the continuation phase) are consistent with WHO recommendations.21,23,38,41 2. NTP has a written policy for selecting which confirmed MDR-TB patients will begin an MDR- Yes TB regimen, who is responsible for applying the selection criteria,p and where these patients are referred for treatment.38 3. Confirmed MDR-TB cases are started on treatment with a WHO-recommended MDR-TB 100% of cases with confirmed MDR-TB start on regimen (output indicators in worksheets 2, 6A, 6B).21,23,38 treatment11,17–19 in programs that follow international guidelines15 4. MDR-TB patients undergo initial evaluation and standard periodic monitoring for adverse Yes reactionsq as recommended by WHO.23,38 5. Algorithms, ancillary drugs, and other therapies are available to manage side effects of Yes
o Especially household contacts whose initial evaluation found they did not have active TB. p Some countries have certain exclusion criteria when they are first launching the treatment of MDR-TB. q Includes tests for pregnancy and renal, liver, and thyroid function, provided at no cost to the patient.
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Essential Elements Target MDR-TB treatment.38,48 6. The effectiveness of MDR-TB treatment is monitored with sputum bacteriology at least Yes monthly until smear and culture conversion, then at least monthly for smears and quarterly for cultures.23,38 7. Directly observed therapy for MDR-TB treatment is provided for the full duration of therapy Yes by a health worker (or trained volunteer functioning under health worker supervision).38 8. Patients with MDR-TB should be treated using mainly ambulatory care (in the home or Yes outpatient clinic) to minimize hospitalization and improve patient access to treatment.23,38,49 9. Social, economic, and psychological factors that may make patients interrupt treatment are Yes identified and addressed.14,21,41 10. Incentives and enablers are available to support MDR-TB patients and their families.38 Yes 11. Efforts are routinely made and documented to retrieve MDR-TB patients who interrupt Yes treatment or miss appointments.21 12. There is a referral system for continuity of care when MDR-TB patients are transferred from Yes one treatment location to another (such as hospital, prison, clinic, region).50 13. An expert committee consults on individual MDR-TB patients and monitors program Yes management for MDR-TB.38 14. The country’s treatment of TB patients with mono- or poly-drug resistance patterns (other Yes than resistance to both isoniazid and rifampicin) is consistent with WHO recommendations.21,38 Next steps a. NTP policy defines which groups of suspected MDR-TB cases have a high enough level of ___#, % eligible suspected MDR-TB cases enrolled in multidrug resistance to warrant use of an empiric MDR-TB regimen while awaiting confirmation MDR-TB treatment19 of MDR-TB (if rapid DST methods are not yet available).21 b. For MDR-TB patients not receiving MDR-TB treatment, a written NTP policy addresses Yes patient education and support, separation if infectious, and palliative care.38 c. Hospitalization is available for MDR-TB patients needing acute level of care due to severity Yes of TB, adverse effects of medications, or concurrent medical conditions.38 d. An MDR-TB Center of Excellence provides consultation and accepts referrals of difficult Yes cases.41 e. Surgical interventions are available for MDR-TB patients.38 Yes 1D. Ensure effective drug supply and management [See also training in component 3A.] First steps 1. Second-line drugs (SLDs) used to treat MDR-TB meet WHO prequalification standards or Yes Stringent National Medicine Regulatory Authority standards.16,43 2. SLDs are ordered, distributed, and stored so that adequate suppliesr of SLDs at each level Yes are available to treat the identified MDR-TB cases.38
r With sufficient remaining shelf life. Includes sufficient buffer stock.
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Essential Elements Target Next steps a. An electronic system is used to manage SLD forecasting, procurement, supply, and Yes distribution.51 1E. Monitor and evaluate performance and impact [See also coordination in component 1A and training in component 3A.] First steps 1. NTP uses WHO definitions and WHO formats for recording and reporting MDR-TB cases Yes from facilities to sub-national levels to national level to WHO.38 2. Data on MDR-TB are analyzed and used to improve NTP performance in expanding access Yes to MDR-TB diagnosis and treatment.16 3. Systematic supervision from national to sub-national to facility levels compares practice to Yes guidelines and is used to improve performance detecting and treating MDR-TB.38,50 4. The NTP’s monitoring and evaluation (M&E) plan includes an MDR-TB component, which Yes specifies periodic external monitoring.38,52 Next steps a. NTP analyzes routine, continuous DST surveillance of TB patients starting re-treatment to Yes15 determine the proportion of multidrug resistance in each of the following groups: failure, ___#, % of confirmed MDR-TB cases detected among TB relapse, and return after default. 21,38,s patients tested17,19 __% MDR in each subgroup of previously treated patients21 b. DST results are reported from a drug resistance survey (DRS) in new cases conducted in Yes the past 3 to 5 years. If DST surveillance of previously treated patients is not yet routine, re- treated patients are also sampled during the DRS.35,38 c. Routine practices are in place to ensure the quality of MDR-TB data, to include regular Yes cross-checking of laboratory and MDR-TB registers and supervisory visits.38,44,53 d. Data are analyzed to describe the frequency of HIV infection among MDR-TB patients and Yes the frequency of multidrug resistance among HIV-positive TB patients.38 e. Delays between MDR confirmation and the patient starting MDR-TB treatment are Mean number of days between the date of DST results measured. Deaths are also recorded among confirmed MDR-TB cases who died before showing resistance to isoniazid and rifampicin and the starting treatment.19,38 date the patient started second-line drug regimen19 f. Full DST patterns of a recent MDR-TB cohort are analyzed and the empiric MDR-TB regimen Yes is adjusted accordingly.21,35,38 g. Individual MDR-TB patient data are entered or uploaded in an electronic case-based Yes15 database at the national level.38,54 2. Address TB/HIV, MDR-TB, and the needs of poor and vulnerable populations 2A. Scale up collaborative TB/HIV activities [See also TB case finding in component 1B, training in 3A, and infection control in 3B.]
s Data are utilized to guide MDR-TB case-finding strategies. (If rapid DST methods are not yet available, these data are also used to select which patient groups have high enough levels of multidrug resistance to warrant an empiric MDR-TB treatment regimen while awaiting their DST results for isoniazid and rifampicin.)
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Essential Elements Target First steps 1. MDR-TB patients know their HIV status.21,41,55 100% of TB patients know their HIV status11,12,15 2. HIV-positive MDR-TB patients begin antiretroviral therapy (ART) as soon as possible after 100% of HIV-positive TB patients start (or continue) on starting TB treatment.21,42,56 ART11,12,15 3. HIV-positive MDR-TB patients begin cotrimoxazole preventive therapy as soon as possible 100% of HIV-positive TB patients start (or continue) on after starting TB treatment.21 cotrimoxazole preventive therapy11,12,15 4. HIV-positive MDR-TB patients receive HIV care and support.21 Yes Next steps a. Provider-initiated HIV testing and counseling is offered to all suspected MDR-TB cases.21,41,55 Yes 2B. Scale up prevention and management of MDR-TB [These elements are distributed across the other relevant Stop TB Strategy components] 2C. Address the needs of TB contacts and of poor and vulnerable populations [See also components 1A. for contacts and 1C for social support.] First steps 1. Prisons are linked to the NTP for MDR-TB diagnosis, reporting, and treatment (including Yes continuity of care upon transfer between facilities or release to the community).38 2. Additional vulnerable populations are identified and linked to the NTP for MDR-TB case Yes detection, reporting, and treatment.14 Next steps a. To judge equitable access to MDR-TB diagnosis and treatment, characteristics of detected ___#, % confirmed MDR-TB cases starting MDR-TB MDR-TB cases are analyzed and compared to those entering MDR-TB treatment.19 treatment among MDR-TB cases detected19 for key subgroupst 3. Contribute to health system strengthening based on primary care 3A. Help improve … human resource development … [See also political commitment in component 1A and management and supervision in 1E.] First steps 1. A focal person is assigned responsibility for human resources development for the detection Yes and treatment of MDR-TB.5,38 2. An assessment of the human resource requirements for MDR-TB includes a task analysis Yes by level of the health system and category of health worker, as well as implications for the existing workforce.38,u 3. Gaps in numbers of staff with requisite skills are defined based on the MDR-TB task Yes analysis and the current staffing available at each level of the health system.5,38 4. To address the gaps, the country has developed a plan for staffing, training, supervision, Yes and support for MDR-TB services without detriment to other areas of NTP work.5,38 5. Key staff in the needed categories are available with the professional competence and Yes support to meet country targets for detection and treatment of MDR-TB.5,38,43 6. Key staff members have been recently trained on drug-resistant TB. 38,v Yes
t Subgroup characteristics may include HIV status, ART status, age, gender, rural/urban, immigrants, migrants, or diagnosis outside NTP. u Consider clinical, managerial, laboratory, and pharmacy workforce.
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Essential Elements Target Next steps a. Implementation of the human resources development plan for MDR-TB scale-up is regularly Yes monitored with revision as necessary.5,38 3B. Strengthen infection control in health services, other congregate settings, and households [See also supervision in component 1E and training in component 3A.] First steps Implement managerial measures 1. A national TB infection control plan addresses settings where care is provided to people Yes (plan for infection control in health facilities providing with known or suspected MDR-TB.41,49 services to people living with HIV)15 2. Facilities providing care to MDR-TB patients are assessed for risk of TB transmission.49 Yes 3. In priorityw facilities, a focal person works with a local coordinating body to develop, Yes implement, and monitor a facility-specific infection control plan, to include the administrative, environmental, and respiratory protection controls listed below to prevent TB transmission.49 Implement administrative controls 4. People known or suspected to have infectious MDR-TB are promptly identified, separated, Yes instructed in cough etiquette, and “fast tracked” to receive services (triaged) so their time in the facility is minimized.49 5. If hospitalized, patients known or suspected to have infectious MDR-TB are isolated Yes following WHO recommendations for airborne precautions. 49,57,x 6. Health workers are given appropriate TB infection control information and encouraged to Yes undergo HIV testing and counseling.49,58 7. Health workers who develop signs or symptoms of TB undergo TB diagnostic investigation, Yes and data are compiled on the number of health workers diagnosed with TB.49 Implement environmental controls 8. In patient care areas of health care facilities, natural ventilation is maximized where Yes possible.49,59 Implement respiratory protection programs 9. Within a comprehensive respiratory protection program, health workers use particulate Yes respirators when caring for patients known or suspected to have infectious MDR-TB.49 Next steps a. TB infection control is part of the country’s overall infection control policy.49 Yes
v Country to define which staff and how frequently. w Countries will prioritize settings depending on the findings of the risk assessments. Higher priority should be given to settings where TB is drug- resistant, exposed people are especially vulnerable to developing disease if infected or dying if they develop TB (such as people living with HIV), exposure is of longer duration (such as hospitals or any setting with diagnostic delays), control measures are lacking, or a large number of people are exposed. During the scale-up process, additional settings will be added to the priority list and additional infection control measures will be phased in. x Including at least 12 air changes per hour.
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Essential Elements Target b. National surveillance of TB disease among health workers is established.49 Ratio of TB notification rate among health care workers to notification rate among the general population is ~1.15 c. Patient care areas in health care facilities have adequate ventilation.49,59 Yes 4. Engage all providers [See also MDR-TB planning in component 1A and training in 3A.] First steps 1. Health care providers outside the NTP (nongovernmental organizations, academic centers, ___% of notified TB cases are reported from non-NTP hospitals) referring, diagnosing, or treating MDR-TB patients are formally linked to the care providers15 NTP.38,43,60 Next steps a. The source of MDR-TB patient referral (by major categories of provider) is routinely reported Yes in the lab or treatment register.38,60,61 b. Outcomes of any MDR-TB patients treated outside the NTP are reported and analyzed as a Yes cohort.52,60 c. Laboratories (including private) outside the NRL network that perform first-line and/or Yes second-line DST report results to NRL.60 5. Empower people with TB and communities through partnership [See also political commitment in component 1A, MDR-TB treatment in 1C, and training in 3A.] First steps 1. MDR-TB patients are provided high-quality patient-centered care, as outlined in the The Yes Patient’s Charter for Tuberculosis Care.16,38,39 2. Community-based DOTS providers support MDR-TB patients.16,38 Yes Next steps a. MDR-TB is included in the country’s ACSM strategy.16 Yes 6. Enable and promote research [See also M&E in component 1E and training in 3A.] Next steps a. Research agenda based on country specific priorities includes MDR-TB.16,62 Yes b. Results of operational research are used to improve MDR-TB services.16 Yes
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