Treatment FAQ

what method monitors the effectiveness of tb treatment

by Mertie Kirlin DDS Published 3 years ago Updated 2 years ago

The use of sputum smear microscopy and culture rather than sputum smear microscopy alone is recommended for the monitoring of patients with multidrug-resistant TB
multidrug-resistant TB
Certain factors such as psychiatric illness, alcoholism, drug additiction and homelessness can predict non-adherence to treatment. Poor compliance with the treatment is also an important factor in the development of acquired drug resistance. Diabetes mellitus has been a well-known risk factor for TB in the past.
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(MDR-TB) during treatment (conditional recommendation/very low quality evidence) (2).

What tests are done to monitor tuberculosis?

Cohort analysis is the key management tool used to evaluate the effectiveness of the national TB control programme. It enables the identification of problems, so that the programme managers and staff can institute appropriate action to overcome them …

What is video observed therapy for tuberculosis?

 · Testing to Monitor Tuberculosis Treatment Lab tests are performed during tuberculosis treatment to determine if any TB bacteria are left in your body. Sputum tests, which examine the thick mucous...

How is the response to tuberculosis treatment measured?

Considering the global epidemic of drug resistance in Mycobacterium tuberculosis, early and accurate diagnosis as well as prompt initiation of antitubercular therapy (ATT) forms the mainstay of tuberculosis control programs.

Can microscopic observation assays detect drug resistant tuberculosis?

1) Health care providers may prescribe DOT as a method to monitor the adherence of a patient to his or her prescribed treatment for tuberculosis disease. Health care providers may utilize the Department’s TB Standards of Care as a guideline for appropriate utilization of DOT.

Which treatment method is used in tuberculosis?

The usual treatment is: 2 antibiotics (isoniazid and rifampicin) for 6 months. 2 additional antibiotics (pyrazinamide and ethambutol) for the first 2 months of the 6-month treatment period.

What is TB monitoring?

Tuberculosis surveillance monitors and analyzes data on tuberculosis disease (mycobacterium tuberculosis), tuberculosis infection and mycobacterium and other tuberculosis and tuberculosis-like disease. Data collected include, but are not limited to, demographic, diagnostic and geographic information.

How can clinicians determine whether a patient is responding to TB treatment?

Patient Medical Evaluation Treating TB disease with an LTBI treatment regimen can lead to drug resistance (see the Preventing Drug Resistance section in this Module). To rule out TB disease, clinicians should determine whether the patient has symptoms of TB disease and evaluate the patient with a chest x-ray.

Which test will give information about which antibiotics will be effective against TB?

Test for TB Infection The Mantoux tuberculin skin test is performed by injecting a small amount of fluid called tuberculin into the skin in the lower part of the arm. The test is read within 48 to 72 hours by a trained health care worker, who looks for a reaction (induration) on the arm.

How is TB surveillance done?

The National Tuberculosis Surveillance System collects information on each newly reported case of tuberculosis (TB) disease in the United States. The program is a cooperative effort of the Centers for Disease Control and Prevention (CDC) and state and local health departments, who report cases of TB to CDC.

What is MX test?

A Mantoux test is a skin test that is used to detect infection by Mycobacterium Tuberculosis (TB). It is used to determine any immune response in the skin, by any individual who could have been or is being exposed to the bacteria.

What are IGRA results based on?

IGRA interpretations are based on the amount of IFN-g that is released or on the number of cells that release IFN-g. Both the standard qualitative test interpretation (positive, negative, or indeterminate) and the quantitative assay measurements (Nil, TB, and Mitogen concentrations or spot counts) should be reported.

What is the other name of TB Gold test?

QuantiFERON-TB Gold (QFT) is a simple blood test that aids in the detection of Mycobacterium tuberculosis, the bacteria which causes tuberculosis (TB). QFT is an interferon-gamma (IFN-γ) release assay, commonly known as an IGRA, and is a modern alternative to the tuberculin skin test (TST, PPD or Mantoux).

How do I know if my TB is getting better?

Physical signs of tuberculosis treatment success include:A reduction in symptoms, such as less coughing.Overall improvement in the way one feels.Weight gain.Increased appetite.Improvement in strength and stamina.

What is the most accurate test for tuberculosis?

The most commonly used diagnostic tool for tuberculosis is a skin test, though blood tests are becoming more commonplace. A small amount of a substance called tuberculin is injected just below the skin on the inside of your forearm. You should feel only a slight needle prick.

What is Genexpert test?

Introduction: Gene-Xpert, a CBNAAT (catridge based nucleic acid amplification test) is a widely accepted diagnostic test for Tuberculosis. This test is a rapid diagnostic test for Tuberculosis detection as well as Rifampicin resistance in direct smear negative cases.

Which test is used to identify the organism that causes TB?

What is a TST? The Mantoux tuberculin skin test is a test to check if a person has been infected with TB bacteria. How does the TST work? Using a small needle, a health care provider injects a liquid (called tuberculin) into the skin of the lower part of the arm.

What is the goal of a tuberculosis treatment plan?

The goal of the treatment plan is to achieve treatment to cure by the least restrictive means.

What are the barriers to treatment for TB?

Patients with TB often face issues that complicate and can act as barriers to treatment, such as substance abuse, homelessness, unemployment, and lack of healthcare access. Effective case management may obviate the need for legal interventions.

What is LTBI treatment?

The final two bullets address treatment for latent tuberculosis infection (LTBI). Treatment of LTBI is generally initiated after the possibility of TB disease is excluded, and has been proven to greatly reduce the risk that individuals latently infected with TB will progress to TB disease.

What is direct observation therapy?

1) Health care providers may prescribe DOT as a method to monitor the adherence of a patient to his or her prescribed treatment for tuberculosis disease. Health care providers may utilize the Department’s TB Standards of Care as a guideline for appropriate utilization of DOT.

How often does DOT have to be done?

The provision of DOT on a daily, twice weekly or three times weekly basis shall continue until discontinued by the health care provider.

What is the duty of a person with tuberculosis?

If, upon examination, it shall be determined that such person has tuberculosis in an active stage or in a communicable form, then it shall be the duty of such [person with tuberculosis] to arrange for admission of himself or herself as a patient in some medical care facility qualified to treat persons with tuberculosis or when there is no danger to the public or to other individuals as determined by the health officer, such person may receive treatment on an outpatient basis. Kan. Stat. Ann. § 65-116b (2009).

What is the responsibility of a health officer for testing for tuberculosis?

The health officer shall: 1) Direct that testing for tuberculosis infection using a Centers for Disease Control and Prevention approved method be performed on contacts of cases of tuberculosis in a communicable stage. 2) Recommend appropriate treatment for latent tuberculosis infection; and 3) Provide for the supervised presumptive treatment of latent tuberculosis infection for a child younger than 4 years old identified as a close contact to a confirmed case or suspected case of active pulmonary tuberculosis. Md. Code Regs. 10.06.01.21 (2009).

How many people died from TB in 2014?

In 2014, 1.5 million people globally died from tuberculosis (TB) ( 1 ). Most TB patients are eminently curable by an affordable course of treatment, although this treatment currently takes a minimum of 6 months to complete and 2 years or longer for multidrug-resistant tuberculosis (MDR-TB) ( 2 ). Millions of patients begin TB treatment each year but face constant challenges to comply with daily medication, causing many to adhere inconsistently or to stop prematurely. Treatment interruption increases the risk for acquired drug resistance, treatment failure, disease progression, relapse and death; it also prolongs transmissibility ( 3 ). Loss to medical follow-up is higher when patients have a negative treatment experience, such as when access to care involves substantial travel time, lost earnings, and other patient expenditures; when adverse drug reactions are frequent or consequential; or conversely, when patients feel better and their motivation to finish treatment declines ( 4 ). For many, treatment is complicated by concomitant health conditions (e.g., HIV/AIDS) and destabilizing socio-structural factors (e.g., substance abuse, homelessness, poor health care access). New medicines currently under study bring renewed hope to TB patients of safer, simpler, and more effective regimens; however, all of these treatments still require several months to complete, making adherence a continuing concern for the future ( 1 ).

What is a TPP in digital health?

In early 2015, a multi-partner collaboration, led by WHO and the European Respiratory Society, started to elaborate target product profiles (TPPs) for digital health products focused specifically on topical challenges in the implementation of the new End TB Strategy ( 5,13 ). A TPP describes the characteristics and requirements for a particular concept under development to help different stakeholders, including developers, define solutions to address specific problems. Participants in these discussions define the nature of the problem to be addressed, its relative priority compared with other pressing needs, and match the need to an existing or forthcoming digital solution. Mindful of the positive early results, but also the need for appropriate, evidence-based guidance on its use, the WHO/ERS initiative has identified VOT as one of the digital tools in support of treatment adherence to be followed closely with a TPP ( 13 ). We propose to take forward the TPP of VOT as a collaborative group of partners. This process will embrace a broad cross-section of representative users, developers, and policy makers. If evidence for the effectiveness of VOT continues to grow, technical details should be elaborated to guide further development and the eventual large-scale deployment of VOT. One of these is the model by which software will be made available, conceivably through open-source or socially responsible licensing ( 14, 15 ). Whichever approach is adopted, a sustainable means to enable VOT interventions worldwide, such as through public funds or insurance systems, will be needed.

Is VOT a new technology?

VOT remains a relatively new and emerging technology, with limited knowledge about its effectiveness and limitations. To understand these effects and make the best use of precious public health resources, VOT must be evaluated under more diverse conditions and settings to define its function and compare it with other existing or emerging technologies geared for the same purposes within an evolving landscape (e.g., short message service [texting] communication and electronic medication monitors). Likewise, synergies between digital health and traditional approaches to improve patient treatment outcomes, and even between different digital health technologies, should be explored.

What are the drugs that treat TB?

Food and Drug Administration (FDA) for the treatment of TB disease (Table 6.2). In addition, the fluoroquinolones (levofloxacin, moxifloxacin, and gatifloxacin), although not approved by the FDA for TB disease, are commonly used to treat TB disease caused by drug-resistant organisms or for patients who are intolerant of some first-line drugs. Rifabutin, approved for use in preventing Mycobacterium avium complex disease in patients with HIV infection but not approved for TB disease, is useful for treating TB disease in patients concurrently taking drugs that interact with rifampin (e.g., certain antiretroviral drugs). Amikacin and kanamycin, nearly identical aminoglycoside drugs used in treating patients with TB disease caused by drug-resistant organisms, are not approved by the FDA for treatment of TB.

How long does it take to treat TB?

As a general rule, the principles used for the treatment of pulmonary TB disease also apply to extrapulmonary forms of the disease. A 6-month treatment regimen is recommended for patients with extrapulmonary TB disease, unless the organisms are known or strongly suspected to be resistant to the first-line drugs. If PZA cannot be used in the initial phase, the continuation phase must be increased to 7 months. The exception to these recommendations is central nervous system TB, for which the optimal length of therapy has not been established but some experts recommend 9 to 12 months. Most experts do recommend corticosteroids to be used as additional therapy for patients with TB meningitis and pericarditis. Consultation with a TB expert is recommended.

What are the four drugs that are included in the initial treatment regimen?

Four drugs— INH, RIF, PZA, and EMB — should be included in the initial treatment regimen until the results of drug-susceptibility tests are available. Each of the drugs in the initial regimen plays an important role. INH and RIF allow for short-course regimens with high cure rates. PZA has potent sterilizing activity, which allows further shortening of the regimen from 9 to 6 months. EMB helps to prevent the emergence of RIF resistance when primary INH resistance is present. If drug-susceptibility test results are known and the organisms are fully susceptible, EMB need not be included. For children whose clarity or sharpness of vision cannot be monitored, EMB is usually not recommended except when the risk of drug resistance is high or for children who have “adult-type” (upper lobe infiltration, cavity formation) TB disease.

How long is the TB continuation phase?

The continuation phase of treatment is given for either 4 or 7 months. The 4-month continuation phase should be used in patients with uncomplicated, noncavitary, drug-susceptible TB, if there is documented sputum conversion within the first 2 months. The 7-month continuation phase is recommended only for

What is the recommended treatment regimen based on?

The recommended treatment regimens are based, in large part, on evidence from clinical trials and are rated on the basis of a system developed by the U.S. Public Health Service (USPHS) and the Infectious Diseases Society of America (IDSA) (Table 6.3).

How to educate patients about TB?

Educating patients about TB disease helps ensure their successful completion of therapy. Health-care providers must take the time to explain clearly to patients what medication should be taken, how much, how often, and when. Patients should be clearly informed about possible adverse reactions to the medications they are taking and when to seek necessary medical attention. Providing patients with the knowledge they need regarding the consequences of not taking their medicine correctly is very important. In addition, patients should be educated about infection control measures and potential need for isolation (Table 6.1). HIV testing and counseling is recommended for all patients with TB disease in all health-care settings. The patient must first be notified that testing will be performed. The patient has the right to decline HIV testing and counseling (opt-out screening).

How long does it take to develop a TB control plan?

For each patient with newly diagnosed TB disease, a specific treatment and monitoring plan should be developed in collaboration with the local TB control program within 1 week of the presumptive diagnosis. This plan should include:

How to diagnose tuberculosis?

In all adults with radiographic abnormalities consistent with tuberculosis, vigorous efforts should be made to establish a microbiologic diagnosis . These efforts should include induction of sputum by inhalation of hypertonic saline. Bronchoscopy with appropriate biopsies and bronchoalveolar lavage should be considered for patients unable to produce a satisfactory sputum specimen. If no other diagnosis can be established, presumptive treatment for tuberculosis may be indicated. In such adults, the major indicators of response to therapy are the chest radiograph and clinical evaluation. The intervals at which chest films should be repeated will depend on the clinical circumstances and the differential diagnosis being considered. Failure of the radiograph to improve after 3 mo of chemotherapy is strongly suggestive that the abnormality is the result of either previous (not current) tuberculosis or another process. If the tuberculin reaction is positive and other diagnoses have been excluded, isoniazid and rifampin can be continued for a total of 4 mo. In children with suspect tuberculosis, microbiologic data can be gained from early morning gastric aspirates or urine. In complicated cases or severely ill children, bronchoalveolar lavage should be considered. An aggressive diagnostic approach in children with HIV infection or pneumonia that is unresponsive to standard treatment should be taken. Specimens for smear, culture, and susceptibility tests should be collected from all children for whom culture and susceptibility information is not available in their adult contact whenever possible.

What are the new drugs that have been evaluated for tuberculosis?

These include amikacin, quinolones, rifamycin derivatives, clofazimine, and beta-lactams (9). None of these agents has been tested in multidrug regimens for treating tuberculosis; however, the recent increase in the occurrence of multidrug- resistant tuberculosis may create more situations where the use of these drugs must be considered. None of these drugs has been evaluated in well- designed, randomized trials for tuberculosis treatment or prophylaxis, and they should not be used to replace any of the previously recommended drugs until efficacy is established. Among the new drugs that have been studied as antituberculosis agents, the ones that are discussed subsequently include only those that are licensed or those that are available through an investigational new drug (IND) request, in the United States. Appropriate doses and intervals for the use of these drugs for tuberculosis have not been established. When available, doses are provided. If these drugs are used in infants and children, appropriate adjustments should be made in consultation with tuberculosis experts.

What is the best treatment for HIV?

A 6-mo regimen consisting of isoniazid, rifampin, and pyrazinamide given for 2 mo followed by isoniazid and rifampin for 4 mo is the preferred treatment for patients with fully susceptible organisms who adhere to treatment. Ethambutol (or streptomycin in children too young to be monitored for visual acuity) should be included in the initial regimen until the results of drug susceptibility studies are available, unless there is little possibility of drug resistance (i.e., there is less than 4% primary resistance to isoniazid in the community, and the patient has had no previous treatment with antituberculosis medications, is not from a country with a high prevalence of drug resistance, and has no known exposure to a drug-resistant case). This four-drug, 6-mo regimen is effective even when the infecting organism is resistant to INH. This recommendation applies to both HIV-infected and uninfected persons. However, in the presence of HIV infection it is critically important to assess the clinical and bacteriologic response. If there is evidence of a slow or suboptimal response, therapy should be prolonged as judged on a case by case basis.

How much therapy is needed for extrapulmonary tuberculosis?

Extrapulmonary tuberculosis should be managed according to the principles and with the drug regimens outlined for pulmonary tuberculosis, except for children who have miliary tuberculosis, bone/joint tuberculosis, or tuberculous meningitis who should receive a minimum of 12 mo of therapy.

Why is preventive therapy important?

Priorities for preventive therapy take into consideration the risk of developing tuberculosis compared with the risk of isoniazid toxic ity (53). Recommendations for the use of isoniazid are based on a comparison of the risk of hepatic injury during the period of treatment with the potential lifelong benefit of preventive therapy. Also of importance is the benefit to society derived from preventive therapy because prevention of tuberculosis precludes the spread of new infection.

What is the target of fluoroquinolones?

A number of fluoroquinolones have been developed that show in vitro activity against M. tuberculosis. The target of the quinolones is a DNA gyrase. Ofloxacin and ciprofloxacin are compounds in this family that are licensed for use in the United States. Neither of these drugs is licensed for the treatment of tuberculosis.

Why is it important to use fixed drug combinations?

The use of fixed drug combinations may enhance patient adherence and may reduce the risk of inappropriate monotherapy, and it may prevent the development of secondary drug resistance. For this reason, the use of such fixed drug combinations is strongly encouraged in adults.

What is TB intervention?

We defined “intervention” as any population level, public health or clinical (at primary, secondary or tertiary level) activity which prevents further cases of active TB or latent TB infection (LTBI), and which has the potential to reduce the incidence of TB at local, regional or national level. This broad definition of “intervention” would include: actions specifically designed for/targeted at TB control/case prevention; clinical approaches, such as different diagnostic methods and drug regimens; areas of activity defined by particular patient groups, e.g. HIV co-infected, multidrug-resistant (MDR)-TB, vulnerable groups, pregnant women, or settings such as healthcare facilities and prisons; and areas of action defined by level of intervention, e.g. social and healthcare systems. Our analysis was stratified by type of effect, distinguishing reviews of interventions which reported a quantifiable “direct effect” from those which had an “indirect effect” on reducing TB incidence or preventing TB cases ( table 1 ). Pre-specified reasons for excluding reviews were: not a systematic review; no intervention evaluated; no direct or indirect effect in preventing TB cases/reducing TB incidence; and economic evaluation only (see Appendix S2 for inclusion checklist). We did not exclude systematic reviews which included studies set in countries with high TB incidence if the review included at least one study in a low TB-incidence setting. As an adjunct to our main analysis, we included reviews of “risk factors” which could modify the effects of interventions or which, if targeted in a hypothetical intervention, could lead to a reduction in TB incidence. Our aim with regard to risk factors was to highlight possible future areas for intervention, particularly those which currently fall outside conventional TB-focused public health or clinical approaches to reducing TB incidence or which could reduce or enhance the effectiveness of conventional interventions.

What databases are used to search for TB?

The following databases were searched from inception to May 2017: MEDLINE, EMBASE, CINAHL, Scopus, Global Health, Trip, Cochrane Library, Social Policy and Practice, HMIC (Health Management Information Consortium), DoPHER (Database of Promoting Health Effectiveness Reviews), Health Systems Evidence and National Guideline Clearinghouse. In addition, the PROSPERO systematic reviews register and the International Journal of Tuberculosis and Lung Disease were searched within the same period. Full search strategies are shown in Appendix S1. In brief, we used a search filter developed by L ee et al. [ 12 ], combined with MeSH and title word terms for tuberculosis, mycobacterium and TB. To search databases of reviews, health evidence or guidelines, we simply used terms for tuberculosis/TB. No language or date restrictions were imposed.

What are the limitations of systematic reviews?

The main limitation of a “review of reviews” approach is that evidence from primary studies will not be assessed if those studies have not been systematically reviewed. Where studies have been reviewed, some “detail” may be lost because we are synthesising evidence which has already been synthesised. We did report some pertinent details from individual studies included in systematic reviews, where these primary studies provided the only evidence for a particular intervention, but unreplicated single-study evidence must be interpreted with caution. It has also been argued that systematic reviews may fail to capture effects of complex interventions, such as DOT, particularly where simplified outcome measures are used [ 218 ]. This is an area where qualitative systematic reviews could potentially contribute to evidence of effectiveness. Where we found sufficient evidence for effects of interventions on TB incidence, we did not attempt to quantify the magnitude of these effects. For example, BCG vaccination of infants in high-risk groups will have little impact on overall TB incidence and case numbers in low-incidence countries because children represent a small proportion of TB cases. As a public health intervention in low-incidence countries, BCG will be more effective in preventing life-threatening paediatric TB cases, e.g. meningitis, than in reducing overall TB incidence.

What is the success rate of XDR TB?

Pooled analysis indicates overall treatment success rates of 26% and 60% for extensively drug-resistant (XDR)- and MDR-TB patients, respectively [ 139 ]. No core reviews were found in relation to approaches to MDR-TB treatment ( e.g. drug regimens). Some of the supplementary reviews of drug regimens made specific recommendations, e.g. linezolid for the treatment of XDR-TB or fluoroquinolone-resistant MDR-TB [ 135] and six- and four-drug combinations in the intensive and continuation phases of XDR-TB treatment [ 141 ], but the common conclusion was the urgent need for more RCTs of MDR- and XDR-TB treatments. Three core reviews were identified in relation to preventive treatments for contacts of MDR-TB cases, two of which found no evidence of effectiveness [ 130, 132 ]; a third was focused on adverse events, finding no evidence of these [ 131 ]. Overall, there is insufficient review level evidence for effects of interventions on MDR-TB incidence in MDR-TB cases or contacts.

What is systematic review?

Systematic reviews are a recognised method for compiling and assessing the findings of multiple systematic reviews into one accessible and usable summary of the evidence base [ 7, 8 ]. The objective of the present review was: 1) to identify systematic reviews of interventions to reduce TB incidence and prevent TB cases in settings of low TB incidence; 2) to assess the quality of the reviews in relation to direct and indirect effects of the interventions on TB incidence; and 3) to summarise the overall strength of evidence for each reviewed intervention. We focused on reviews of interventions for which reduction in TB incidence and prevention of TB cases was a measurable outcome, but our broad definition of “intervention” also encompassed approaches to TB diagnosis and treatment which could have an indirect impact on TB incidence. The overall aim of the review was to provide an evidence base to inform the development and implementation of national TB plans.

Is a TB test accurate?

Diagnostic accuracy of TB diagnostic tests in different patient groups is increasingly well-characterised. There is insufficient review level evidence either to support or discount direct effects of interferon γ-release assays (IGRAs) compared with tuberculin skin test (TST) in predicting which cases of LTBI would progress to active TB, i.e. the two tests are similar in predictive value (high negative predictive value, low positive predictive value). There is sufficient review level evidence of indirect effects on TB incidence of performing molecular drug susceptibility testing. This assessment was based on three core reviews of molecular drug susceptibility testing: 1) a UK HTA review of GenoType MTBDRplus (isoniazid (INH) and rifampicin), INNO-LiPA Rif.TB (rifampicin) and Xpert MTB/RIF (rifampicin) [ 51 ]; 2) a Cochrane review of the Xpert MTB/RIF assay [ 54 ]; and 3) a review of three commercial line probe assays, Hain Genotype MTBDRplusV1, MTBDRplusV2 and Nipro NTM+MDRTB [ 52 ]. The conclusion of all three reviews was that molecular tests had high sensitivity and specificity (regardless of HIV status) for rifampicin and INH resistance, e.g. for rifampicin resistance detection Xpert MTB/RIF pooled sensitivity and specificity were 95% and 98%, respectively [ 54 ].

Is LTBI treatment effective for HIV?

There is sufficient review level evidence to support LTBI treatment and antiret roviral therapy (ART) to prevent active TB in people infected with HIV, although this evidence derives mainly from studies in low- or middle-income countries. Of the three core reviews: one reviewed LTBI treatment in HIV-positive adults based on 12 RCTs, finding a reduced risk of active TB comparing various anti-TB drug regimens with placebo, particularly among patients with a positive TST [ 115 ]; another review in HIV-positive children also reported a marked reduction in risk of active TB, but based on a single RCT [ 116 ]; and a review of ART for prevention of TB in adults based on three RCTs and eight other studies found a substantial reduction in TB incidence [ 117 ].

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