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Reference Guide Asking the Right Questions A Visual Guide to Tuberculosis Case Management for Nurses

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Page 1: Asking the Right Questions...Asking the Right Questions: A Visual Guide to TB Case Management | Reference Guide, 2010 The Francis J. Curry National Tuberculosis Center is a joint project

Reference Guide

Asking the Right QuestionsA Visual Guide to Tuberculosis Case Management for Nurses

Page 2: Asking the Right Questions...Asking the Right Questions: A Visual Guide to TB Case Management | Reference Guide, 2010 The Francis J. Curry National Tuberculosis Center is a joint project

Asking the Right Questions: A Visual Guide to TB Case Management | Reference Guide, 2010

The Francis J. Curry National Tuberculosis Center is a joint project of the San Fran-cisco Department of Public Health and the University of California, San Francisco, funded by the Centers for Disease Control and Prevention (CDC) under CDC Coop-erative Agreement U52 CCU 900454.

Permission is granted for nonprofit educational use and library duplication and distri-bution.

Suggested citation:

Francis J. Curry National Tuberculosis Center. Asking the Right Questions: Reference Guide. San Francisco, CA; 2010: [inclusive pages].

This publication is available on the Francis J. Curry National Tuberculosis Center website at www.nationaltbcenter.edu/arq/.

Design: Edi Berton Design

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Page 1 Asking the Right Questions: A Visual Guide to TB Case Management | Reference Guide 2010

Contents Contents ................................................................................................... 1

Introduction ............................................................................................. 2

About this Project........................................................................... 2

Why Are Questions Important? ...................................................... 2

Why Understand the Whole TB Case Management Process? ...... 3

The Right Questions Quick Reference List ........................................... 5

Throughout Case Management .............................................................. 8

Understanding TB Case Management Goals and Tasks .............. 8

Ensuring that the Patient Understands TB .................................. 10

Completing the Patient’s Chart .................................................... 11

Taking Special Considerations into Account ............................... 12

During Assessment ............................................................................... 13

Determining the Risk for TB ......................................................... 13

Knowing When to Suspect TB ..................................................... 14

Gathering Information to Evaluate the Patient’s TB Disease ....... 19

Determining the Patient’s Infectious Period ................................. 25

Learning about the Patient’s Culture and Beliefs ......................... 27

Ensuring that the Patient’s Basic Needs are Met ........................ 29

During Treatment .................................................................................. 30

Ensuring Completion of Therapy ................................................. 30

Monitoring the Patient’s Response to Treatment ......................... 33

Monitoring for Adverse Reactions ................................................ 37

Determining When Treatment Is Completed ............................... 38

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Introduction

About this ProjectPurposeUse the Asking the Right Questions educational toolkit to

• Prompt your critical thinking about TB case management

• Find relevant basic national training materials

• Get an overview of the full TB case management timeline

Online Educational ToolkitGo to the Asking the Right Questions Web Guide at www.nationaltbcenter.ucsf.edu/arq/ to download the Asking the Right Questions Visual Guide to TB case manage-ment, usable as a poster or smaller reference sheet. While on the website, you also can interactively review the TB case management timeline, explore the right ques-tions list, hyperlink directly to national training materials and guidelines, and access an online glossary.

Why Are Questions Important?No Step-by-Step Procedures TB cannot be assessed or treated using a set of step-by-step procedures. Instead, to assess and treat TB requires applying guidelines to each patient’s situation.

To assess or diagnose TB, you can use several different sets of criteria depending upon the patient’s situation. Each patient can present TB signs and symptoms differ-ently, depending upon factors such as age, immune system status, coexisting dis-eases, area of the body affected, and severity of the TB disease.

In assessment, for example, a standard test for pulmonary TB (acid-fast bacilli spu-tum smear microscopy) cannot detect the disease in its early stages, although the patient may have TB symptoms and be infectious. Sometimes a patient with TB dis-ease may not have a cough if the immune system is suppressed or if they are under age 5, and HIV-positive patients with TB disease can have normal-appearing chest x-rays. Further, a patient can have culture-negative TB disease and be clinically diag-nosed to have TB. In that case, a TB diagnosis requires starting empiric TB treatment and learning from the patient’s response if he or she has TB.

Multiple factors can affect the choice of a TB treatment regimen. When planning how to treat a TB patient and when monitoring the patient while on treatment, you need to consider many aspects of the patient’s situation, such as:

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Asking the Right Questions: A Visual Guide to TB Case Management | Reference Guide, 2010Page 3

• Extent and site of the TB disease

• Drug resistance

• Other conditions, such as HIV, diabetes, arthritis

• Age

• Mental health and substance abuse

• Stability of residence

• Culture and beliefs about healthcare and TB

• Language

These factors can impact the choice of treatment regimen, how it is delivered, and how you can help the patient to adhere to 6 to 12 months of treatment. Further, many of these factors can change during a patient’s treatment.

Critical Thinking Because a set of step-by-step procedures will not fit all patients, you need to gather and review the data for each patient’s medical and psychosocial situation and work with your team to apply guidelines for assessment and treatment. This requires that you think critically—and the key to critical thinking is asking yourself good questions.

To recognize good questions, it helps to understand the TB case management pro-cess, be familiar with national guidelines (and local guidelines and protocols where available), and to carefully look at the data about your patient.

Why Understand the Whole TB Case Management Process?Understanding the whole process of TB case management prompts you to ask the questions that you need to answer in order to meet TB case management goals and to understand the impact of your decisions and work throughout the TB case manage-ment process.

TB Case Management GoalsAsking good questions ensures make sure that you and the team meet TB case management goals for your patient:

• The patient is assessed, a medical evaluation is performed by a physician, and a treatment plan is established

• The patient is educated about TB and its treatment

• Treatment is promptly started with directly observed therapy and is continuous, safe, and completed

• Contacts are identified, screened, and evaluated and those who are eligible started on treatment for latent TB infection

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The Impact of Your WorkYour decisions will affect whether and when to suspect TB, the quality of assess-ment data collected, treatment planning and start date, the patient’s understanding of TB, the patient’s willingness and ability to adhere to treatment, and the safety and effectiveness of treatment.

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The Right Questions Quick Reference List

Throughout Case Management

? What are your goals and tasks to case manage this confirmed or suspected TB patient? What goals and tasks does your TB case management work involve? (Go to p.8) What is your role as a healthcare worker in TB treatment? (Go to p. 8)

? After you provide information, has the patient explained back an accurate and complete understanding about TB and its treatment? What is missing or misunderstood? What is your process for educating this patient about TB? (Go to p.10)

? Could someone pick up the patient’s chart and know what’s going on? Does the team regularly document all patient data and interventions? (Go to p. 11) Is the patient’s treatment plan documented? (Go to p. 11)

? Are there special considerations to take into account about your patient: HIV, pregnancy, breastfeeding, younger than 4 years old, extrapulmonary TB, diabetes, kidney dialysis, or any drug resistance? Where do you find information on conditions requiring special consideration? (Go to p. 12)

During Assessment

? How do you know that the patient is at risk for TB? What are the patient’s risk factors for TB? (Go to p. 13) What are the risk factors for multidrug-resistant TB (MDR TB)? (Go to p. 13)

? Why do you suspect that this patient has TB: TB symptoms? Abnormal chest x-ray? History? How is latent TB infection different from active TB disease? (Go to p. 14) How does latent infection progress to active disease? (Go to p. 15)

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Does this patient have any history, signs, or symptoms associated with pulmonary TB disease? (Go to p. 16)

Does this patient have any risk factors for multidrug-resistant TB (MDR TB)? (Go to p. 13) Does this patient have any characteristic or condition that may mask typical signs and

symptoms of TB disease? (Go to p. 18) How do you prevent transmission if your patient is a TB suspect? (Go to p. 26)

? How do you know that you can accurately describe the patient’s TB disease? Was there a complete medical evaluation? (Go to p. 19) What information do you have about this patient’s medical history? (Go to p. 19) What did the patient’s physical examination reveal? (Go to p. 19) What tests were ordered to diagnose TB infection, and what test results were reported? (Go to

p. 20) Were chest-x-rays ordered, and, if so, what did they show? (Go to p. 21) What bacteriologic tests were ordered to diagnose TB disease and what information did they

provide? (Go to p. 22) Were rapid tests ordered for TB disease and multidrug-resistant TB (MDR TB)? (Go to p. 23) Where and when was the patient interviewed? (Go to p. 24) What questions was the patient asked? (Go to p. 24) What infection control precautions were taken for this patient? (Go to p. 26)

? On what evidence did you determine the patient’s infectious period? When did the patient’s symptoms begin, and how reliable is your evidence for that date? (Go

to p. 25) Who were the patient’s contacts and where were potential transmission sites during the

infectious period? (Go to p. 25)

? How did the patient describe her/his culture and initial beliefs about TB? What cultural competency skills have you used with this patient? (Go to p. 27) Where did you find information on the patient’s culture? (Go to p. 27) Have you used an appropriate interpreter, if needed? (Go to p. 28)

? How do you know whether or not your patient can get food, shelter, clothing, transportation, and health care? What enabler(s) have you used with this patient? (Go to p. 29) What referrals to other services did you provide for this patient? (Go to p. 29)

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During Treatment

? Is DOT happening as mutually agreed upon? Has the patient been observed swallowing each dose of anti-TB medication? (Go to p. 30) What are the terms of the patient’s DOT agreement? (Go to p. 30) What other strategies are you using to foster adherence to treatment? (Go to p. 31) Are you using them in order from least restrictive to more restrictive? (Go to p. 32)

? How do you know whether or not the patient is responding to treatment? What clinical observations are made to check for response to treatment and how frequently?

(Go to p. 33) What bacteriologic tests did you order and how frequently? (Go to p. 34) If ordered, what did the chest x-rays show? (Go to p. 35) What signs and symptoms do you check to know if the patient is not responding to treatment?

(Go to p. 36)

? How have you checked for signs and symptoms of adverse reactions or side effects? How do you check the patient for signs and symptoms of an adverse reaction to anti-TB

medication? Have you documented the adverse reactions? (Go to p. 37) Have you educated the patient on what to do if there are symptoms of an adverse reaction?

Have you documented this patient’s education? (Go to p. 37) What is your plan of action if the patient shows signs and symptoms of an adverse reaction?

Have you documented the plan of action? (Go to p. 38)

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Throughout Case Management

Understanding TB Case Management Goals and TasksRole of the Healthcare WorkerThe responsibility for TB control and prevention in the United States rests with the public health system through federal, state, county, and local public health agencies. To ensure that patients complete TB treatment, public health agencies use a case management model in which a health department employee is assigned responsibil-ity for the management of specific patients, including monitoring patients for adverse reactions to anti-TB medications.

Healthcare workers outside of the public health department at community clinics, hospitals, private medical offices, correctional facilities, and skilled nursing facilities also play important roles. Often they are the first to detect a patient’s TB signs and symptoms. Throughout assessment and treatment, they may be involved in caring for the patient, forming an important part of the case management team.

Responsibilities of the TB Case ManagerIn case management, the health department employee designated as the case man-ager is assigned primary responsibility and is held accountable for ensuring that:

• The patient is assessed, a medical evaluation is performed by a physician, and a treatment plan is established

• The patient is educated about TB and its treatment

• Treatment is promptly started with directly observed therapy and is continuous, safe, and completed

• Contacts are identified, screened, and evaluated and those who are eligible started on treatment for latent TB infection

Although one person is assigned primary responsibility, case management provides continuity of care by using a team of persons who work together to help each patient complete treatment.

• CDC. Self-Study Modules on Tuberculosis:“What Is the Role of the Public Health Worker in TB Treatment?” (Module 4, p. 45) www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

“What is Case Management?” (Module 9, pp. 12-13) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

Throughout Case Management

The case manager is

assigned primary

responsibility

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• CDC. MMWR:“Controlling Tuberculosis in the United States: Recommendations from the American Thoracic Society, CDC, and the Infectious Diseases Society of America” www.cdc.gov/mmwr/PDF/rr/rr5412.pdf

• New Jersey Medical School Global Tuberculosis Institute. Tuberculosis Case Management for Nurses: Self-Study Modules:

“Overview of Public Health and Public Health Nursing” (Module 1, pp. 1-19) www.umdnj.edu/globaltb/downloads/products/Nursing%20Module%201.pdf

“Fundamentals of Tuberculosis Case Management” (Module 2, pp. 3-20) www.umdnj.edu/globaltb/downloads/products/Nursing%20Module%202.pdf

Throughout Case Management

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Ensuring that the Patient Understands TBPatient Education Before you begin educating a patient about TB, find out how much the patient may already know about TB.

To present new information, use effective communication techniques such as the following:

• Use simple, nonmedical terms

• Use the appropriate language level

• Limit the amount of information

• Discuss the most important topics first and last

• Repeat important information

• Listen to feedback and questions from the patient

• Use concrete examples

• Make the interaction with the patient a positive experience

To be certain that a patient has an accurate understanding, ask the patient what has just been explained and what is understood. Do this with concern and care so that the patient does not feel threatened. Spend extra time reviewing important infor-mation.

• CDC. Self-Study Modules on Tuberculosis:

“Examples of Open-Ended Questions for Patient Assessment” (Module 9, p. 17) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

“Effective Communication Techniques” (Module 9, pp. 27-31) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

• Cultural Competency topic (Go to p. 26)

• Professional Medical Interpreters topic (Go to p. 27)

Throughout Case Management

Ask the patient what

has just been explained

and what is understood

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Completing the Patient’s ChartRecommended Documentation The nurse case manager must ensure that documentation is completed regularly by all members of the case management team. Document all interventions in a clear and concise manner to support continuation of appropriate care. A chart audit tool offers a way to check your documentation.

TB Treatment PlanFor each patient with newly diagnosed TB, develop a specific treatment and monitor-ing plan within one week of the suspected diagnosis. If you work in a community clinic, hospital, or other setting outside of the local health department, collaborate with your local health department when developing the treatment plan. This plan should include:

• A description of the treatment regimen

• Methods of monitoring for adverse reactions

• Methods of assessing and ensuring adherence to the treatment

• Methods for evaluating treatment response

• New Jersey Medical School Global Tuberculosis Institute. Tuberculosis Case Management for Nurses: Self-Study Modules:

“Fundamentals of Tuberculosis Case Management: Documentation” (Module 2, pp. 19-20)

“Plan Development” and “Appendix 4: Elements of a Treatment Plan for Patients with TB” (Module 2, pp. 14, 26-27)www.umdnj.edu/globaltb/downloads/products/Nursing%20Module%202.pdf

• CDC. Self-Study Modules on Tuberculosis:“Treatment and Monitoring Plan” (Module 4, p. 34)www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

• Washington State Department of Health. Washington State Tuberculosis Services Manual: Tuberculosis Chart Audit Tool www.doh.wa.gov/cfh/TB/Manual/Forms/ChartAudit.pdf

Throughout Case Management

Document all interventions

in a clear and concise

manner

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Asking the Right Questions: A Visual Guide to TB Case Management | Reference Guide, 2010

Throughout Case Management

Page 12

Taking Special Considerations into AccountSpecial Considerations for TB Assessment and TreatmentThe situations listed below require additional or different testing and tasks during TB assessment and treatment:

• HIV

• Pregnancy

• Breastfeeding

• Age Under 4

• Diabetes

• Kidney Dialysis

• Drug Resistance

• Extrapulmonary TB

Consult a TB expert and the resources below to understand how best to assess and treat a patient with one or more of these conditions.

CAUTION: HIV-positive patients should be referred to HIV/AIDS specialists and have their TB treatment administered in consultation with those specialists.

• CDC. Self-Study Modules on Tuberculosis: “Treatment Regimens” (Module 4, pp. 29-31) www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

• CDC. MMWR: “Treatment of Tuberculosis” (pp. 50-66)www.cdc.gov/mmwr/PDF/rr/rr5211.pdf

Consult a TB expert

and national guidelines

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Assessment

Asking the Right Questions: A Visual Guide to TB Case Management | Reference Guide, 2010Page 13

During Assessment

Determining the Risk for TBHigh-Risk Groups Information about a patient’s medical condition, age, TB exposure, place of birth, travel and immigration, residence, workplace, socioeconomic situation, lifestyle, and substance abuse are important in assessing risk for TB. High-risk groups can be divided into two categories:

• People who are at high risk for becoming infected with Mycobacterium tuberculosis

• People who are at high risk for developing TB disease once infected with M. tuberculosis

In the Self-Study Modules on Tuberculosis, the CDC lists these groups in “Table 3.1: Groups at High Risk for LTBI and TB Disease.” Refer to p. 7 of Module 3 online at www.cdc.gov/tb/education/ssmodules/pdfs/Module3.pdf.

Risk for Multidrug-Resistant TB (MDR TB) Drug resistance is more common in people who:

• Have had a previous episode of TB treatment

• Have had inadequate or improper current TB treatment (patient not taking medi-cations regularly, breaks in treatment, wrong drugs prescribed, treatment dura-tion too short)

• Are not responding to current TB treatment

• Have come from, or frequently travel to, areas of the world where drug-resis-tant TB is common

• Have spent time with someone known to have drug-resistant TB disease

Order rapid molecular drug susceptibility testing on smears for patients from areas with endemic MDR TB or with past exposure to MDR TB.

• CDC. Self-Study Modules on Tuberculosis: “Groups at High Risk for LTBI and TB Disease” (Module 3, pp. 6-7) www.cdc.gov/tb/education/-ssmodules/pdfs/Module3.pdf

• CDC. Multidrug-Resistant Tuberculosis (MDR TB) Fact Sheet www.cdc.gov/tb/publications/factsheets/drtb/mdrtb.htm

• Francis J. Curry National Tuberculosis Center. Drug-Resistant Tuberculosis: A Survival Guide for Clinicianswww.nationaltbcenter.ucsf.edu/products/product_details.cfm?productID=WPT-11CD

• World Health Organization. Multidrug and Extensively Drug-resistant TB (M/XDR-TB): 2010 Global Report on Surveillance and Response http://whqlibdoc.who.int/publications/2010/9789241599191_eng.pdf

• See the Rapid Tests for TB Disease and Drug Resistance topic (Go to p. 22)

Carefully consider

information about your

patient to assess risk

for TB

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Assessment

Asking the Right Questions: A Visual Guide to TB Case Management | Reference Guide, 2010Page 14

Knowing When to Suspect TBClassification System for TBThe current classification system is based on the pathogenesis of TB. Many health-care providers use this system to describe patients.

• Be aware that a Class 3 patient should be receiving treatment for TB

• Note that a Class 5 patient may require treatment if the suspicion of TB is mod-erate or high

• Promptly report the case or suspected case on treatment to the local or state health department

Classification System for TB

Class Type Description

0 • No TB exposure

• Not infected

• No history of TB exposure

• Negative result to a TST or IGRA

1 • TB exposure

• No evidence of infection

• History of TB exposure

• Negative result to a TST (given at least 10 weeks after exposure) or to an IGRA

2 • TB infection

• No TB disease

• Positive result to a TST or to an IGRA

• Negative smears and cultures (if done)

• No clinical or x-ray evidence of active TB disease

3 • TB, clinically active

• Positive culture (if done) for Mycobacterium tuberculosis

• Positive result to a TST or to an IGRA, and clinical, bacteriological, or x-ray evidence of TB disease

4 • Previous TB disease (not clinically active)

• Medical history of TB disease

• Abnormal but stable x-ray findings

• Positive result to a TST or to an IGRA

• Negative smears and cultures (if done)

• No clinical or x-ray evidence of current TB disease

5 • TB suspected • Signs and symptoms of TB disease, but evaluation not complete

IGRA = interferon gamma release assay; TST = tuberculin skin test

The current classification

system is based on the pathogenesis

of TB

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Assessment

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Progression to TB DiseaseProgressing from TB infection to TB disease means that the body cannot fight the TB bacteria and they begin to multiply. Before there are enough TB bacteria in the lungs to confirm TB disease, the patient may feel unwell and may have symptoms such a cough, loss of weight, bloody sputum, and weakness. Often to relieve symptoms, the patient makes several visits to a doctor, clinic, or hospital. Healthcare workers in hos-pitals and community clinics as well as public health should always “Think TB” to prevent delays in diagnosis.

• CDC. Self-Study Modules on Tuberculosis:

“Classification System for TB” (Module 1, pp. 25-26) www.cdc.gov/tb/education/ssmodules/pdfs/Module1.pdf

“Latent TB Infection (LTBI)” and “LTBI vs . TB Disease” (Module 1, pp. 13-14) www.cdc.gov/tb/education/ssmodules/pdfs/Module1.pdf

“Pathogenesis” (Module 1, pp.12-21) www.cdc.gov/tb/education/ssmodules/pdfs/Module1.pdf

• CDC and ATS. American Journal of Respiratory Critical Care Medicine:“Diagnostic Standards / Classification of TB in Adults and Children” (pp. 1377-78,1391-92) www.cdc.gov/tb/publications/PDF/1376.pdf

Always “Think TB”

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Assessment

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When to Suspect TB Disease[ ! ] Suspect TB in any patient who has a persistent cough for more than two to three weeks (and does not respond to over-the-counter medications), or who has other compatible signs and symptoms. Ask the patient to use a surgical mask or tissue to cover the mouth.

[ ! ] Medically evaluate for TB disease anyone with symptoms of TB or anyone found to have a positive tuberculin skin test or interferon gamma release assay.

When to Suspect Pulmonary TB in AdultsSuspect pulmonary TB and start to assess a patient when the features, signs, symp-toms, and findings listed below occur in an adult. Be aware that the clinical presenta-tion of TB varies considerably as a result of the extent of the disease and the patient’s response.

Historic Features

• Exposure to a person with infectious TB• Positive test result for Mycobacterium tuberculosis infection• Presence of risk factors, such as immigration from a high-prevalence area, HIV

infection, homelessness, or previous incarceration* • Diagnosis of community-acquired pneumonia that has not improved after 7 days of

treatment †• Previous treatment for latent TB infection or disease

Signs and Symptoms Typical of TB

• Prolonged coughing (≥2–3 weeks) with or without production of sputum that might be bloody (hemoptysis)§

• Chest pain• Chills

• Fever• Night sweats• Loss of appetite• Weight loss• Chronic malaise and fatigue

Chest Radiograph: Immunocompetent patients

• Classic findings of TB are upper-lobe opacities, frequently with evidence of contraction fibrosis and cavitation

• In patients with diabetes, atypical presentation is more common with exclusive lower lobe disease ¶

Chest Radiograph: Patients with advanced HIV infection

• Lower-lobe and multilobar opacities, hilar adenopathy, or interstitial opacities might indicate TB

* See the High-Risk Groups topic. (Go to p. 13)

† Patients treated with levofloxacin or moxifloxacin may have a clinical response when TB is the cause of the pneumonia.

§ Do not wait until sputum is bloody to consider a productive cough a symptom of TB. Sputum produced by coughing does not need to be bloody to be a symptom of TB.

¶ These features are not specific for TB, and, for every person in whom pulmonary TB is diagnosed, an esti-mated 10–100 persons are suspected on the basis of clinical criteria and must be evaluated. Information on patients with diabetes from Kawamura, LM. Diabetes and Tuberculosis: Converging Epidemics. Presentation at the National TB Conference. Atlanta, GA; June 24, 2010.

Suspect TB in any patient

who has a persistent cough for

more than 2 to 3 weeks,

or other compatible

signs and symptoms

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Assessment

Asking the Right Questions: A Visual Guide to TB Case Management | Reference Guide, 2010Page 17

• CDC. Self-Study Modules on Tuberculosis: “Diagnosis of TB Disease” (Module 3, pp. 41-42) www.cdc.gov/tb/education/ssmodules/pdfs/Module3.pdf

• CDC and ATS. American Journal of Respiratory Critical Care Medicine:“Diagnostic Standards / Classification of TB in Adults and Children” (pp. 1378-81) www.cdc.gov/tb/publications/PDF/1376.pdf

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Assessment

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Conditions that Mask TB Signs and SymptomsPeople with TB disease may or may not have symptoms. In many patients, TB is as-sociated with other medical and social conditions such as HIV infection, diabetes mellitus, kidney failure, cancer, homelessness, alcohol or drug abuse, malnourish-ment, and diseases that require immunosuppressive drugs. The signs and symptoms of these conditions and their complications can easily mask those of TB and result in considerable delays in diagnosis, especially in patients with HIV infection.

Factors that Influence the Clinical Features of TB

Host (Patient) Factors Microbial (TB Strain) Factors

Host (Patient) – Microbe (TB Strain) Interaction

Age

Immune status

• Specific immunodeficiency states

• Malnutrition

• Genetic factors (not yet defined)

Coexisting diseases

Immunization with bacillus Calmette-Guérin (BCG)

Virulence of the organism

Predilection (tropism) for specific tissues

Sites of involvement

Severity of disease

TB should still be considered a diagnosis in asymptomatic patients who have risk factors for TB and abnormal chest x-rays compatible with TB. If a patient is symp-tomatic, do not be fooled by a negative TB test. A negative tuberculin skin test or interferon gamma release assay never “rules out” active TB or TB disease. Active TB itself or other immunocompromising conditions often cause falsely negative tests because TB tests require a healthy immune system to react. Extrapulmonary TB should be considered if there are risk factors and general symptoms of TB (such as weight loss, fever, or night sweats) and no pulmonary symptoms. The symptoms of extrapulmonary TB depend on the part of the body that is affected by the disease.

• CDC and ATS. American Journal of Respiratory Critical Care Medicine:“Diagnostic Standards / Classification of TB in Adults and Children” (pp. 1378-81) www.cdc.gov/tb/publications/PDF/1376.pdf

• CDC. MMWR:“Tuberculosis Associated with Blocking Agents Against Tumor Necrosis Factor-Alpha – California, 2002–2003” www.cdc.gov/mmwr/PDF/wk/mm5330.pdf

A patient with TB disease may or may

not have symptoms

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Gathering Information to Evaluate the Patient’s TB DiseaseMedical EvaluationA complete medical evaluation for diagnosing TB disease includes:

• Medical history

• Physical examination

• Testing for TB infection

• Chest x-rays

• Bacteriologic examination and culture (may include molecular testing)

Medical HistoryTo document medical history, ask whether the patient has:

• Any symptoms of TB disease

• Been exposed to a person with infectious TB or has risk factors for exposure to TB

• Risk factors for developing TB disease

• Had latent TB infection or prior TB disease

• Any previous treatment for latent TB infection or TB disease

Suspect TB disease in patients with any of these factors.

Physical ExaminationA physical examination can provide valuable information about the patient’s overall condition and factors that may affect how TB disease is treated, if diagnosed. How-ever, a physical examination cannot confirm or rule out TB disease. At a minimum, a physical examination should include:

• Temperature and weight

• Overall assessment of nutritional status (pale conjunctiva may indicate anemia of chronic disease)

• Lymph node palpation

• Heart and lung examination

• Extremity examination looking for signs of chronic lung disease such as blue fingers or clubbing of the fingernails

• CDC. Self-Study Modules on Tuberculosis: “Diagnosis of TB Disease” (Module 3, pp. 40-43) www.cdc.gov/tb/education/ssmodules/pdfs/Module3.pdf

• CDC and ATS. American Journal of Respiratory Critical Care Medicine:“Diagnostic Standards / Classification of TB in Adults and Children” (pp. 1376-95)www.cdc.gov/tb/publications/PDF/1376.pdf

• Patient Interviews topic (Go to p. 23)

A complete medical

evaluation includes five components

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Testing for TB InfectionTwo types of tests are available to test for TB infection: the TB skin test (TST) and blood tests.

Tuberculin Skin Test (TST)

You can use a Mantoux (TST) to determine if a person is infected with Mycobacterium tuberculosis. In this test, you inject tuberculin (also known as purified protein deriva-tive, or PPD) into the skin.

Interferon Gamma Release Assays (IGRAs)

IGRAs are blood tests that measure a person’s immune reactivity to M. tuberculosis. Currently available IGRAs include QuantiFERON®-TB Gold (QFT-G), QuantiFERON®-TB Gold In-Tube (QFT-GIT), and T-SPOT®.TB (T-Spot) tests.

• CDC. Self-Study Modules on Tuberculosis: “Targeted Testing and the Diagnosis of Latent Tuberculosis Infection and Tuberculosis Disease” (Module 3, pp. 8-39) www.cdc.gov/tb/education/ssmodules/pdfs/Module3.pdf

• CDC. MMWR:“Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection” (pp. 1-51) www.cdc.gov/mmwr/PDF/rr/rr4906.pdf

• CDC. MMWR:“Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection — United States, 2010” (pp. 1-25)www.cdc.gov/mmwr/PDF/rr/rr5905.pdf

Two types of tests are available to test for TB

infection

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Chest X-Rays for AssessmentDuring assessment, chest x-rays (CXRs) are used to:

• Help rule out the possibility of pulmonary TB disease in a person who has a positive tuberculin skin test (TST) or a positive QuantiFERON®-TB Gold (QFT-G), QuantiFERON®-TB Gold In-Tube (QFT-GIT) or a T-SPOT®.TB (T-Spot) result

• Check for lung abnormalities in people who have symptoms of TB disease

Sometimes an abnormal chest x-ray provides the first clue that your patient has pul-monary TB. In this situation, get a full TB symptom and medical history, administer a TST or interferon gamma release assay (IGRA), and collect three sputum specimens for acid-fast bacilli (AFB) sputum smear microscopy and culture. Sputum specimens are the best means to promptly test for pulmonary TB. Collect the sputum specimens 8 to 24 hours apart, with at least one being an early morning specimen. On all first-time sputum specimens, obtain a rapid molecular detection test called a nucleic acid amplification test (NAAT) or use a molecular detection of drug resistance test.

The results of a chest x-ray, however, cannot confirm that a person has TB disease. A variety of illnesses may produce abnormalities whose appearance on a chest x-ray resembles TB.

In persons living with HIV, pulmonary TB disease may have an unusual appearance on the chest x-ray. The chest x-ray may even appear entirely normal.

• CDC. Self-Study Modules on Tuberculosis: “Diagnosis of TB Disease: The Chest X-Ray” (Module 3, pp. 46-47) www.cdc.gov/tb/education/ssmodules/pdfs/Module3.pdf

• Francis J. Curry National Tuberculosis Center. Radiographic Manifestations of Tuberculosis: A Primer for Clinicianswww.nationaltbcenter.ucsf.edu/products/product_details.cfm?productID=EDP-04

• CDC and ATS. American Journal of Respiratory Critical Care Medicine:“Diagnostic Standards / Classification of TB in Adults and Children” (pp. 1378-79) www.cdc.gov/tb/publications/PDF/1376.pdf

Chest x-rays help rule out

pulmonary TB disease and

check for lung abnormalities

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Bacteriologic Examination for AssessmentClinical specimens (for example, sputum or urine) are examined and cultured (grown) in the laboratory for the bacteriologic examination. TB bacteriologic examination is done in a laboratory that specifically deals with Mycobacterium tuberculosis and oth-er mycobacteria.

The bacteriologic examination has five parts:

1. Specimen collection

2. Direct smear for examination acid-fast bacilli (AFB)

3. Nucleic acid amplification test (NAAT) for direct identification of M. tuberculosis from the first sputum specimen

4. Culture and identification

5. Drug susceptibility testing

Collect three sputum specimens for AFB sputum smear microscopy and culture 8 to 24 hours apart, with at least one being an early morning specimen. On all first-time sputum specimens, obtain the rapid molecular detection NAAT. If the first culture re-sults are positive, order drug susceptibility tests. If susceptibility testing shows isonia-zid and rifampin resistance, order testing on susceptibility to second-line drugs.

If a patient comes from an area with endemic multidrug-resistant TB or has past ex-posure to multidrug-resistant (MDR TB), order rapid molecular drug susceptibility testing on smears on the first positive culture.

• CDC. Self-Study Modules on Tuberculosis: “Diagnosis of TB Disease: The Bacteriologic Examination” (Module 3, pp. 48-64) www.cdc.gov/tb/education/ssmodules/pdfs/Module3.pdf

• CDC. MMWR: “Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis”www.cdc.gov/mmwr/PDF/wk/mm5801.pdf

• CDC and ATS. American Journal of Respiratory Critical Care Medicine:“Diagnostic Standards / Classification of TB in Adults and Children” (pp. 1381-87) www.cdc.gov/tb/publications/PDF/1376.pdf

Collect three sputum

specimens 8 to 24 hours

apart, with at least one

being an early morning

specimen

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Rapid Tests for TB Disease and Drug ResistanceNucleic Acid Amplification Test (NAAT)

A NAAT can be used for directly identifying Mycobacterium tuberculosis from sputum specimens, avoiding the delay in waiting for a culture result.

If a patient has a positive NAAT or an acid-fast bacilli (AFB)-positive smear, the patient can be presumed to have TB. If a patient has a negative NAAT with an AFB-positive smear, the patient may have a nontuberculous mycobacteria infection. NAAT results can help guide the clinician’s decisions for treatment and isolation; however, they do not replace the need for AFB smear, culture, or clinical judgment.

Molecular Drug Susceptibility Testing

If a patient comes from an area with endemic multidrug-resistant TB (MDR TB), has had prior TB treatment, or has past exposure to MDR TB, order rapid molecular drug susceptibility testing on smears of the first positive culture.

Rapid drug resistance testing may be available from the CDC if your patient is at high risk of MDR TB. The CDC’s Molecular Detection of Drug Resistance (MDDR) test al-lows rapid confirmation of resistance to the first-line drugs rifampin (RIF) and isoniazid (INH). It also can confirm resistance to the most effective second-line drugs: fluoro-quinolones (FQ) and the injectables amakacin (AMK), kanamycin (KAN), and capreo-mycin (CAP). MDDR is a presumptive test and needs to be confirmed by traditional susceptibility testing.

CDC performs confirmation for the first-line drugs (up to 14 days from the receipt of the specimen) and second-line drugs (28 days from the receipt of the specimen). MDDR results are available within three to four business days from the receipt of specimen at the CDC laboratory.

• CDC. Self-Study Modules on Tuberculosis: “Diagnosis of TB Disease: The Bacteriologic Examination” (Module 3, p. 58)www.cdc.gov/tb/education/ssmodules/pdfs/Module3.pdf

• CDC. MMWR: “Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis”www.cdc.gov/mmwr/PDF/wk/mm5801.pdf

• CDC. Report of Expert Consultations on Rapid Molecular Testing to Detect Drug-Resistant Tuberculosis in the United States; 2010www.cdc.gov/tb/topic/Laboratory/rapidmoleculartesting/default.htm

• CDC. Laboratory User Guide: Molecular Detection of Drug Resistance (MDDR) in Mycobacterium tuberculosis Complex by DNA Sequencingwww.cdc.gov/tb/topic/Laboratory/guide.htm

• CDC. Use of the MDDR Service by Submitters [web page] www.cdc.gov/tb/topic/Laboratory/UserGuide/submitters.htm

• Washington State Department of Health. Washington State TB Services Manual:“Chapter 4: Diagnosis of Tuberculosis Disease” (p. 4.20) www.doh.wa.gov/cfh/TB/Manual/Sections/Section4.pdf

A NAAT avoids the

delay in waiting for a

culture result

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Patient Interviews Interview a patient both during the initial assessment and during ongoing assess-ments throughout treatment. The patient interviews collect data to:

• Make decisions for the patient’s treatment and care

• Identify areas where the patient requires education about TB

• Identify adverse reactions to medications

• Guide the contact investigation

Conduct the initial assessment during the patient’s hospitalization, at the first clinic visit, or during a home visit. During treatment, conduct an ongoing assessment monthly. Additional assessments may be needed if the patient has problems with treatment or is nonadherent to directly observed therapy or follow-up appointments.

The case manager needs all medical records in order to provide case management and recommend a case management plan. Prior to the visit with the patient, ensure that a copy of all of the patient’s medical records (from hospitals, clinics, and other healthcare providers) and chest radiographs are available to the treating physician.

Learn about the differences between a patient’s beliefs and your beliefs by asking several open-ended questions. An open-ended question begins with a word that demands an explanation so that it cannot be answered with a simple “yes” or “no.”

• CDC. Self-Study Modules on Tuberculosis:

“Getting to Know the Patient” (Module 9, pp. 14-24) www.cdc.gov/tb/education/ssmodules/module6/ss6recordreview.htm#interview

“Patient Interview” (Module 6, pp. 28-36)www.cdc.gov/tb/education/ssmodules/pdfs/6.pdf

“Strategies for Conducting Effective Interviews” (Module 6, pp. 36-43) www.cdc.gov/tb/education/ssmodules/pdfs/6.pdf

“Open-Ended Questions” (Module 9, pp. 16-24; Module 6, p. 45) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf www.cdc.gov/tb/education/ssmodules/pdfs/6.pdf

• New Jersey Medical School Global Tuberculosis Institute. Tuberculosis Case Management for Nurses: Self-Study Modules “Assessment” (Module 2, pp. 8-11) www.umdnj.edu/globaltb/products/tbcasemgmtmodules.htm

• Professional Medical Interpreters topic (Go to p. 27)

• CDC. Effective TB Interviewing for Contact Investigation: Self-Study Modules www.cdc.gov/tb/publications/guidestoolkits/Interviewing/default.htm

Interview a patient both

during the initial and

ongoing assessments

throughout treatment

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Determining the Patient’s Infectious PeriodInfectious Period and Contact InvestigationThe infectious period is the time period during which a person with TB disease is capable of transmitting Mycobacterium tuberculosis. Determining the infectious pe-riod helps to focus the contact investigation efforts on those persons who were ex-posed while the patient was infectious.

After a complete assessment of the information available, clinical and supervisory staff should estimate the infectious period. There is no universal, well established method to determine the infectious period, but the beginning of the infectious period is usually estimated by determining the date of onset of the patient’s symptoms (es-pecially coughing). Sometimes when it is difficult to obtain a reliable history from the patient about the onset of symptoms, the beginning of the infectious period is esti-mated to be earlier than the onset of symptoms.

For guidance in determining when a patient has become noninfectious, see the topic on Bacteriologic Examination of Response to Treatment (p. 36).

Use the guidelines below to determine whether to conduct a contact investigation. If it is decided to pursue a contact investigation, use interviews with the patient and contacts and field investigations to collect data on contacts and transmission sites. Identify, screen, and evaluate contacts. Start those eligible on treatment for latent TB infection.

• CDC. Self-Study Modules on Tuberculosis:

“The Period of Infectiousness” (Module 6, pp. 25-27) www.cdc.gov/tb/education/ssmodules/pdfs/6.pdf

“Contact Investigations for Tuberculosis” (Module 6, pp. 1-103) www.cdc.gov/tb/education/ssmodules/pdfs/6.pdf

• CDC. MMWR: “Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis: Recommendations from the National Tuberculosis Controllers Association and CDC” www.cdc.gov/mmwr/pdf/rr/rr5415.pdf

Determining the infectious period helps

to focus the contact

investigation efforts

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Infection Control PrecautionsUse of infection control precautions usually are part of a broader infection control program. The main goal of an infection control program is to detect TB disease early and to promptly isolate and treat people who have TB disease. The infection control programs include three types of controls: administrative controls, engineering con-trols, and personal respiratory protection.

For guidance in determining when a patient has become noninfectious, see the topic on Bacteriologic Examination of Response to Treatment (p. 36).

• Francis J. Curry National Tuberculosis Center. Practical Solutions for TB Infection Control: Infectiousness and Isolation [online course]www.nationaltbcenter.ucsf.edu/courses/course_details.cfm?productID=ONL-13

• CDC. Self-Study Modules on Tuberculosis: “Infectiousness and Infection Control” (Module 5, pp. 1-53) www.cdc.gov/tb/education/ssmodules/pdfs/Module5.pdf

• CDC. MMWR: “Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-care Settings, 2005” www.cdc.gov/mmwr/pdf/rr/rr5417.pdf

• Francis J. Curry National Tuberculosis Center. Tuberculosis Infection Control. A Practical Manual for Preventing TB www.nationaltbcenter.ucsf.edu/products/product_details.cfm?productID=WPT-12

“Do Not Board” OrderAsk the TB patient if he or she has any plans to travel in the near future. If the patient has travel plans, be ready to issue a “Do Not Board” order.

A “Do Not Board” order alerts airports and airlines not to allow the patient to board an aircraft. This order is coordinated by the Department of Homeland Security and the Division of Global Migration and Quarantine and is for air travel only.

• Washington State Department of Health:

Do Not Board (DNB) Protocol www.doh.wa.gov/cfh/TB/Manual/Forms/DNBProtocol.pdf Do Not Board (DNB) Questionnaire www.doh.wa.gov/cfh/TB/Manual/Forms/DNBQuestions.pdf

• Division of Global Migration and Quarantine [website]www.cdc.gov/ncpdcid/dgmq/

Infection control

programs include

administrative controls,

engineering controls,

and personal respiratory protection

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Division of Global Migration and Quarantine [website] www.cdc.gov/ncpdcid/dgmq/
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Learning about the Patient’s Culture and BeliefsCultural CompetencyCulture is shaped by experiences and life events that contribute to a person’s beliefs, values, attitudes, and behaviors. Culture can affect the ways in which a person com-municates, both verbally and nonverbally, and understands information. Be aware of the cultural diversity of TB patients, contacts, and healthcare workers and how cul-tural factors may affect assessment and treatment of your TB patient.

Cultural competency is the sensitivity to and awareness of the various factors that shape a person’s identity. It is the ability to work with and care for diverse persons to meet their cultural needs without compromising their health or that of the public.

• CDC. Effective TB Interviewing for Contact Investigation: Self-Study Modules“Module 3: Cultural Competency” www.cdc.gov/tb/publications/guidestoolkits/Interviewing/selfstudy/module3/toc.htm

• Washington State Department of Health. Cultural Competency in Health Services and Care: A Guide for Health Care Providerswww.doh.wa.gov/hsqa/Professions/Publications/documents/CulturalComp.pdf

Resources on Specific Countries and Ethnic GroupsConsult the following resources to research more about your patient’s culture:

• Harborview Medical Center, University of Washington. Ethnomed [Website]http://ethnomed.org/

• CDC. Ethnographic Guides for China, Laos (Hmong), Mexico, Somalia, and Vietnam www.cdc.gov/tb/publications/guidestoolkits/EthnographicGuides/default.htm

• Southeastern National Tuberculosis Center. Quick Reference Guides Country-Specific Guides for Health Professionals Working with Foreign-Born Clients https://sntc.medicine.ufl.edu/Products.aspx

Be aware of how cultural

factors may affect

assessment and treatment

of your TB patient

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Professional Medical InterpretersThe interviewer must gauge when an interpreter is needed. In some cases this is obvious, while in others it is not. The patient’s medical record may mention a lan-guage barrier, so an interpreter can be arranged prior to meeting the patient. A pa-tient may demonstrate language comprehension by nodding his or her head affirma-tively or verbally indicate understanding by saying “yes” or “no” when answering questions.

However, despite some proficiency, the patient may not have an adequate under-standing of the interviewing messages. The responses to open-ended questions re-quire more than a word or two, so they can help the interviewer to judge how much is understood by the answer given. Despite simplifying the language used and basing questions on the patient’s level of understanding, if the patient understands very little of the conversation, it is time to engage an interpreter.

• CDC. Effective TB Interviewing for Contact Investigation: Self-Study Modules:“Working with Interpreters” www.cdc.gov/tb/publications/guidestoolkits/Interviewing/selfstudy/module2/2_6.htm

• CDC. Self-Study Modules on Tuberculosis: “Interpretation Services” (Module 9, pp. 32-35)www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

• Francis J. Curry National Tuberculosis Center Making the Connection: An Introduction to Interpretation Skills for TB Control www.nationaltbcenter.ucsf.edu/products/product_details.cfm?productID=EDP-09

If the patient understands

very little of the

conversation, it is time to engage an interpreter

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Ensuring that the Patient’s Basic Needs Are MetEnablersEnablers are provisions that make it possible or easier for the patients to receive treatment by overcoming barriers such as transportation difficulties.

Referrals for Other ServicesCase management uses a combination of patient-focused services in which the case management team performs tasks that include providing patients with needed health or social services or making referrals to other appropriate service agencies. These referrals are a form of enabler used to improve adherence.

• New Jersey Medical School Global Tuberculosis Institute. Tuberculosis Case Management for Nurses: Self-Study Modules: “Assessment” and “Implementation” (Module 2, pp. 10, 11, 15-16) www.umdnj.edu/globaltb/downloads/products/Nursing%20Module%202.pdf

• CDC. Self-Study Modules on Tuberculosis:

“Using Incentives and Enablers to Improve Adherence” (Module 9, pp. 54-57)www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

“Problem Solving” (Module 9, p. 65)www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

Case management

uses a combination

of patient-focused services

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DOT is the most effective

strategy for making sure that patients

take their medicines

During Treatment

Ensuring Completion of TherapyDirectly Observed Therapy (DOT)A component of case management that helps to ensure that patients adhere to treat-ment is directly observed therapy (DOT). DOT, the most effective strategy for making sure that patients take their medicines, means that a healthcare worker or other des-ignated person watches the patient swallow every dose of the prescribed drugs. DOT should be considered for all patients because it is difficult to reliably predict which patients will be adherent.

• CDC. Self-Study Modules on Tuberculosis:“Using DOT to Improve Adherence” (Module 9, pp. 38-53) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

• Washington State Department of Health Agreement for Directly Observed Therapy (DOT) www.doh.wa.gov/cfh/TB/Manual/Forms/DOTAgree%28King%29.pdf

• Virginia Department of Health Directly Observed Therapy Agreement www.doh.wa.gov/cfh/TB/Manual/Forms/DOTAgree%28King%29.pdf

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TB is nearly always

curable if patients

adhere to their TB treatment

regimen

Adherence StrategiesAdherence to treatment means that a patient follows the recommended course of treatment by taking all the prescribed medications for the entire length of time neces-sary. Adherence is important because TB is nearly always curable if patients adhere to their TB treatment regimen.

Adherence strategies include case management, patient assessment, patient educa-tion, working with an interpreter, directly observed therapy, incentives, and enablers.

• CDC. Self-Study Modules on Tuberculosis:

“Patient Adherence to Tuberculosis Treatment” (Module 9, pp. 6-62) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

“What is Adherence?” and “Reasons for Nonadherence” (Module 9: pp. 6-11)www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

“Patient Assessment” (Module 9:, pp. 16-24) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

“Using Incentives and Enablers to Improve Adherence” (Module 9: pp. 54-59.) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

• New Jersey Medical School Global Tuberculosis Institute. Tuberculosis Case Management for Nurses: Self-Study Modules:“Assessment” and “Implementation” (Module 2, pp. 8-17) www.umdnj.edu/globaltb/downloads/products/Nursing%20Module%202.pdf

• Patient Education topic (Go to p. 10)

• Krueger K, Ruby D, Cooley P, Montoya B, Exarchos A, Djojonegoro BM, Field K. The International Journal Against TB and Lung Disease: “Videophone Utilization as an Alternative to Directly Observed Therapy for Tuberculosis”www.ingentaconnect.com/content/iuatld/ijtld/2010/00000014/00000006/art00019

• Directly Observed Therapy (DOT) topic (Go to p. 29)

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Have a treatment

plan that goes step-by-step

from voluntary participation

Problem Solving and Progressive Interventions for NonadherenceNotify the appropriate supervisory clinical and management staff when patients are nonadherent. The health official or a representative should find out why the patient is nonadherent and begin using strategies that will help the patient finish treatment.

Before legal measures are taken against a patient who has been taking TB drugs on a self-administered basis, offer directly observed therapy to the patient.

Before a court orders involuntary confinement, have a treatment plan that goes step-by-step from voluntary participation to involuntary confinement as a last resort.

• CDC. Self-Study Modules on Tuberculosis:

“Problem Solving: Behavioral Diagnosis” (Module 9, pp 63-79) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

“Legal Remedies” (Module 9, pp. 80-87.) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

“Progressive Interventions” (Module 9, pp. 81-87) www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf

• National TB Controllers Association. TB Law Resources [Web page]http://tbcontrollers.org/?page_id=532

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In a clinical evaluation,

the clinician checks

whether the patient still has TB symptoms

Monitoring the Patient’s Response to TreatmentClinical Observations of Response to TreatmentThe clinician uses three methods to determine whether a patient is responding to treatment: clinical evaluation, bacteriologic examination, and chest x-rays.

In a clinical evaluation, the clinician checks whether the patient still has TB symp-toms. Although each patient responds to treatment at a different pace, all patients’ TB symptoms should gradually improve and eventually go away. During directly ob-served therapy, each week monitor cough, fever, and level of fatigue, and each month, weigh the patient. Patients whose symptoms do not improve during the first two months of treatment, or whose symptoms worsen after improving initially, should be reevaluated.

Public health workers who have regular contact with patients should pay attention to the patient’s improvement. If a patient has symptoms of TB (or of serious adverse reactions), have the patient stop all medications and immediately report the situation to the clinician. Arrange for a medical evaluation and note the symptoms on the pa-tient’s forms.

• When to Suspect TB Disease topic (Go to p. 15)

• CDC. Self-Study Modules on Tuberculosis: “Evaluating Patients’ Response to Treatment” (Module 4, p. 41) www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

• CDC. MMWR “Treatment of Tuberculosis” (pp. 38-9)www.cdc.gov/mmwr/PDF/rr/rr5211.pdf

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Examine specimens

at least every month until the culture

results have converted

from positive to negative

Bacteriologic Examination of Response to TreatmentThe clinician checks a patient’s response to treatment by doing a bacteriologic ex-amination of the sputum or other specimens. Examine specimens at least every month until the culture results have converted from positive to negative.

Follow-up laboratory testing for patients diagnosed with TB can have two purposes: (1) to evaluate whether a patient is infectious and needs to be kept in isolation, and (2) to determine if the treatment is working or needs to be modified.

Sputum test results and clinical improvement are used as primary criteria to deter-mine noninfectiousness. Which set of criteria are used depends upon the patient’s initial test results and the setting into which the patient will be released. [ ! ] If a patient has MDR TB, more stringent criteria apply, and you should consult an expert to de-termine when the patient is noninfectious.

Two consecutive negative cultures indicate response to treatment. Carefully reevalu-ate any patient whose culture results have not become negative after two months of treatment, or whose culture results become positive after being negative. If the pa-tient is still culture positive at three months, consider drug resistance, noncompli-ance, or nonabsorption.

Caution: AFB smears do not distinguish between live and dead bacteria. In cases that have a very high bacillary load, sputum smear conversion can sometimes occur after culture conversion due to the high number of bacteria in the sputum specimen. Clinical response and culture conversion to negative should be used as the definitive measures of treatment response and contagiousness.

• CDC. Self-Study Modules on Tuberculosis: “Evaluating Patients’ Response to Treatment” (Module 4, p. 41) www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

• CDPH/CTCA. CDPH/CTCA Joint Guidelines:Guidelines for the Assessment of Tuberculosis Patient Infectiousness and Placement into High and Lower Risk Settingswww.ctca.org/guidelines/ctca_infectiousness_guidelines.pdf

• CDC. MMWR “Treatment of Tuberculosis” (pp. 38-9)www.cdc.gov/mmwr/PDF/rr/rr5211.pdf

• Reevaluation for Nonresponse to Treatment or Relapse topic (Go to p. 35)

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Treatment

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Repeated x-rays are not

as important as monthly

bacteriologic and clinical evaluations

Chest X-Rays to Assess Response to TreatmentThe clinician can use x-rays to monitor a patient’s response to treatment. Repeated x-rays are not as important as monthly bacteriologic and clinical evaluations. How-ever, an x-ray taken at the end of treatment can be compared with any follow-up x-rays taken subsequently should symptoms recur. X-rays are also useful in evaluat-ing the response of culture-negative cases. In these patients, the bacteriological response cannot be assessed by culture conversion, and the clinician must rely on the clinical and x-ray responses.

• CDC. Self-Study Modules on Tuberculosis: “Evaluating Patients’ Response to Treatment” (Module 4, p. 41) www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

• Francis J. Curry National Tuberculosis Center. Radiographic Manifestations of Tuberculosis: A Primer for Clinicianswww.nationaltbcenter.ucsf.edu/products/product_details.cfm?productID=EDP-04

• CDC. MMWR“Treatment of Tuberculosis” (pp. 38-9)www.cdc.gov/mmwr/PDF/rr/rr5211.pdf

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Treatment

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Reevaluating the patient

means checking for drug

resistance and adherence

Reevaluation for Possible Treatment Failure Promptly reevaluate a patient if

• Symptoms do not improve during the first two months of therapy

• Symptoms worsen after improving initially

• Culture results have not become negative after two months of treatment

• Culture results become positive after being negative

Reevaluating the patient means checking for drug resistance by repeating the drug susceptibility tests and assessing whether the patient has been taking medication as prescribed.

Two consecutive negative cultures indicate response to treatment. Carefully reevalu-ate any patient whose culture results have not become negative after two months of treatment, or whose culture results become positive after being negative. If the pa-tient is still culture positive at three months, the patient may be failing treatment and the following should be considered and evaluated:

• Drug resistance

• Nonadherence

• Nonabsorption

The treatment of TB can be complicated, especially in patients who fail to respond to treatment, who relapse, or who have drug-resistant TB or serious adverse reactions to medications. A new regimen may be required, and treatment may last longer. Clini-cians who do not have experience with these situations should consult a medical expert.

• CDC. Self-Study Modules on Tuberculosis: “Reevaluating Patients” (Module 4, p. 42) www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

• Francis J. Curry National TB Center. Drug-Resistant Tuberculosis: A Survival Guide for Clinicianswww.nationaltbcenter.ucsf.edu/products/product_details.cfm?productID=WPT-11CD

• CDC. MMWR:“Treatment of Tuberculosis” (pp. 39-40; 66-72)www.cdc.gov/mmwr/PDF/rr/rr5211.pdf

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At least monthly

during treatment, a clinician

should see and evaluate each patient for possible

adverse reactions

Monitoring for Adverse Reactions Evaluating the Patient for Adverse Drug ReactionsConsult the CDC treatment guidelines for pretreatment baseline blood and vision testing and for follow-up testing during treatment.

Educate all patients being treated for TB disease about the potential symptoms of adverse reactions to the drugs they are taking. Warn patients about the symp-toms of minor side effects as well as about the symptoms of potentially serious side effects. Instruct patients to stop medications and seek medical attention immedi-ately if they have symptoms of a serious side effect. Refer to the resources below for a symptom list.

At least monthly during treatment, a clinician should see and evaluate each patient for possible adverse reactions. Individualize the monitoring for adverse reactions, de-pending on the patient’s medications and risk for adverse reactions. Ask the patient if there are any of the symptoms of adverse reactions and examine the patient for signs of possible adverse reactions.

In addition, public health workers who have regular contact with patients should ask the patient about adverse reactions at every visit.

• CDC. Self-Study Modules on Tuberculosis: “Monitoring for Adverse Reactions” (Module 4, pp. 34-38) www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

• CDC. MMWR“Treatment of Tuberculosis” (pp. 43-45, 20-32)www.cdc.gov/mmwr/PDF/rr/rr5211.pdf

• When Adverse Reactions Occur topic (G to p. 37)

When Adverse Reactions OccurIf a patient has symptoms of a serious adverse reaction, the public health worker should

• Instruct the patient to stop the medication and report to the case manager or any staff available when symptoms of serious adverse reactions occur

• Immediately report the situation to a clinician and arrange for a medical evaluation

• Note the symptoms on the patient’s form

• CDC. Self-Study Modules on Tuberculosis:“Monitoring for Adverse Reactions” (Module 4, pp. 34-38) www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

• CDC. MMWR“Treatment of Tuberculosis” (pp. 43-45, 20-32)www.cdc.gov/mmwr/PDF/rr/rr5211.pdf

Instruct the patient to

stop the medication and report

when symptoms of serious

adverse reactions

occur

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The total number

of doses ingested and the duration of treatment

determine if treatment

has been completed

Determining When Treatment Is CompletedCalculation of Total Doses/Duration of TreatmentThe total number of doses ingested and the duration of treatment determine if treatment has been completed. For the required number of doses, refer to CDC’s “Treatment of Tuberculosis” guideline.

Evaluation and Patient Education at End of TreatmentIf the patient had no drug resistance, at the end of treatment, instruct the patient to promptly report the development of any symptoms, particularly prolonged cough, fever, or weight loss.

If the patient had drug-resistant TB, at the end of treatment, schedule an individual-ized follow-up evaluation and instruct the patient to promptly report the development of any symptoms, particularly prolonged cough, fever, or weight loss.

• CDC. Self-Study Modules on Tuberculosis:“Treatment Regimens” (Module 4, pp. 25-27) www.cdc.gov/tb/education/ssmodules/pdfs/Module4.pdf

• CDC Task Order 6/Francis J. Curry National Tuberculosis Center. Tuberculosis Program Manual Template: “Treatment of Tuberculosis Disease” (pp. 6.27-28) www.nationaltbcenter.ucsf.edu/research/tb_manual_template.cfm

• CDC. MMWR: “Treatment of Tuberculosis” “Drug Regimens” and “Suggested Doses”(Tables 2-5, pp. 3-5)“Completion of Treatment” (p. 8)www.cdc.gov/mmwr/PDF/rr/rr5211.pdf