Diagnosis & Management of Tuberculosis · 2019-05-03 · Dr Uma Devaraj, Associate Professor, Pulmonary Medicine, St John’s Medical College, Bangalore Dr Priya Ramachandran,

Diagnosis & Management of Tuberculosis

Facilitators Manual

Diagnosis and Management of

Tuberculosis and STCI Doctors Training – Facilitators’ Manual

THALI Doctors Training on the Diagnosis and Management of Tuberculosis

To achieve the overall objective of TB control, this training aims to improve health care provider compliance with the following 5+1 principles drawn from the Standards for TB Care in India:

1. Appropriate health-seeking behavior of people with TB symptoms

2. Evidence-based diagnosis

3. Treatment using standard drug regimens

4. Disease notification

5. Treatment follow-through; compliance and prevention of spread.

This training is designed to be highly interactive and uses the RNTCP’s Technical & Operational Guidelines for Tuberculosis Control, 2016, as the main reference manual.

Doctors Training Tuberculosis Health Action Learning Initiative

Training on Diagnosis and management of Tuberculosis and STCI

Facilitators Manual

The THALI-TB training Participants Manual and Facilitators’ Guide was developed by St John’s Medical College, Bangalore, for the USAID Tuberculosis Health Action Learning Initiative (THALI) intervention implemented by the Karnataka Health Promotion Trust (KHPT).

This training manual has been designed to be participatory and particular attention has been given to ensure that the teaching-learning methodology includes many opportunities for critical reflection as it in reflection that real learning occurs.

The sessions emphasize group discussions and group activities to allow participants to build on and apply their knowledge and experience. Each module contains suggested teaching materials/methods such as group work and drills. However, instructors are encouraged to adapt and supplement the course to make it more relevant to the specific backgrounds and experience of the participants. Depending on the situation, instructors might want to expand the time allocated to lectures or to discussions.

Acknowledgements:Content Specialists and the Authors of the various chapters: Dr Uma Devaraj, Associate Professor, Pulmonary Medicine, St John’s Medical College, BangaloreDr Priya Ramachandran, Professor, Pulmonary Medicine, St John’s Medical College, BangaloreDr Indumathi C K , Professor, Paediatrics, St John’s Medical College, BangaloreDr Mary Dias, Professor, Microbiology, St John’s Medical College, BangaloreDr John Stephen S, Professor, Dermatology, St John’s Medical College, BangaloreDr Prarthana B S, Care and Support Specialist, THALI, KHPTMs Joyce Meshach , Training Coordinator, THALI, St John’s Medical College, Bangalore

Other resource persons who have significantly contributed to the development of this training Manual:Dr George D’souza, Professor, Department of Pulmonary Medicine, St John’s Medical College, BangaloreDr Sanjiv Lewin, Professor, Department of Paediatrics, St John’s Medical College, BangaloreDr Reynold Washington, Senior Technical Director/Advisor, KHPTDr Prakash Kudur, Project Director, THALI, KHPTDr K. Karthikeyan, Technical Specialist, THALI, KHPTDr Shobha Ekka, Technical coordinator, THALI, KHPTDr Aditi Krishnamurthy, Technical Consultant, KHPTDr Sushma J, State Technical Coordinator, THALI, KHPT

For all the support and encouragement, a special thank you to:Rev. Dr. Paul Parathazham, Director, St John’s National Academy of Health Sciences, Bangalore Dr Tony Raj, Dean, St John’s Research Institute, Bangalore

© St John’s -KHPT 2016 All portions of this manual may be reproduced for use in TB Training, provided acknowledgement of the source and notification of such use is given to St John’s Medical College, Bangalore & Karnataka Health Promotion Trust (KHPT).

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ABBREVIATIONS

AFB - Acid Fast Bacilli

ALT - Alanine Transaminase

ART - Anti-Retroviral Therapy

ATT - Anti-Tuberculosis Treatment

CP - Continuation Phase

DMC - Designated Microscopy Center

DOT - Directly Observed Treatment

DOT - Directly Observed Treatment

EPTB - Extra-Pulmonary Tuberculosis

HIV - Human Immunodeficiency Virus

IP - Intensive Phase

STCI - Standards of TB care in India

MDRTB - Multi-drug Resistant Tuberculosis

MO - Medical Officer

NSP - New Smear Positive

PTB - Pulmonary Tuberculosis

RNTCP - Revised National Tuberculosis Control Program

TB - Tuberculosis

USAID - United States Agency for International Development

WHO - World Health Organization

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1. General Instructions for Facilitators 1

2. Introduction 7

3. Diagnosis 9

4. Classification and Initiation of ATT 18

• Disease Classification and Initiation of ATT

• Adherence Preparation

• Referral

5. Monitoring of Anti-Tuberculous Treatment 33

6. Tuberculosis in Children 42

7. Contact Screening and Chemoprophylaxis 54

8. Annexures 57

• Infection Control

• Tuberculosis notification in India: FAQs

• RNTCP Request Form For exmination of biological specimen for TB

• Training program schedule

CONTENTS Participants Workbook

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General Instructions for Facilitators Objectives of trainingTo prepare doctors to provide Tuberculosis care including identification of TB suspects, diagnosis of TB, ATT initiation, support and monitoring.

Purpose of this facilitators guideThis guide is meant to be used to aid in facilitation in conjunction with the Participant Workbook and the “Desktop ready Reckoner” for the Basic TB Training Course for Doctors.

SchedulingThis module has been designed for a one day (6 hours) training workshop and it is preferable that trainees devote the entire 6 hours to training.The sessions are presented in sequential order of the chapters suggesting that session 1 should be covered before session 2. Likewise, the topics within the sessions should follow the suggested sequential order. However, the facilitator can adapt any of the training material depending on the level of training and expertise of the trainees and the availability of time. A sample workshop schedule is included for your convenience (See Annexure ).

Prepare for every topic• Read the entire module thoroughly to see how each topic relates to the next topic• Prepare the materials and resources identified. For e.g. if the module says to use pictures, check whether the pictures are available or make them before the workshop, or if it is recommended to use the black board, see that chalk, duster etc is available, etc.

Pre and post test Explain to participants that the purpose of the pretest is to give facilitators a sense of baseline knowledge of the group, and is not an evaluation. Allow 20-30 minutes for the test of approximately 30 questions. Decide beforehand if test should be anonymous (in which case participants will not know their scores) and what, if any, feedback will be given on test results. Do not discuss answers to the questions when test is finished, as the same test will be given as the post test, but explain that all material will be covered in the course. At least two persons should score the test on the same day it is given so that facilitators can gear each course to the level of knowledge of participants.

Evaluation of the trainingIt is important to see that the participants give a feedback of the workshop that is conducted. This is needed to assess the strengths and weaknesses of the training sessions. Hence there should be time set aside in the schedule of the workshop. Various aspects of the workshop and of the module itself have been considered in the evaluation tool given in Annexure.

Closing the workshopClose the workshop with a wrap up debriefing, tea, distribution of certificates, and an oral feedback from a representative of the participants.

After the training workshopClassroom training is the first step. Participants would need to be supported by providing them information in the form a participant’s workbook, contact numbers or addresses of facilitators or of one person who would be responsible for providing follow-up support of the participants.

Facilitators’ Manual

The workshop trainers / facilitators should be familiar with participatory forms of teaching/learning. The trainers / facilitators should have the ability to ask exploratory open-ended questions and should be sensitive towa rds involving all the trainees. The facilitator should also be technically competent to answer questions related to the training topics.

A variety of teaching methods have been suggested for each topic. These include the following participatory techniques:

This training is particularly designed to be participatory. In order for the sessions to be participatory the “lesson plan” clearly defines the following:

Specific Learning Objectives: The specific learning objectives for each of the sessions have been defined taking into consideration two important factors: (a) the expected task/role of the participant and (b) the limitation with respect to time available for training. Therefore, for each of the sessions, though there may be many content areas that are important, it is imperative that the focus is restricted to the defined specific learning objectives.

Materials Required: Prepare the materials and resources identified. For e.g. if the module says to use pictures, check whether the pictures are available or make them before the workshop, or if it is recommended to use the black board, see that chalk, duster etc is available, etc

Time: The time allotted for the entire session as well as the approximate time for each of the activities of the sessions are mentioned. It is important to stick to the time in order to achieve the defined specific learning objectives.

The training methodology: The training methodology suggested for the activities for each of the sessions should follow the following pattern:

A. An interactive PowerPoint: to introduce the content area

B. The activity: Included are “case scenarios” and “exercises” for group work

C. Group presentation

D. Discussion

E. Summarize using the PowerPoint

Training DesignFacilitators’ Manual

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Possible Teaching Methods

1. Group discussionDiscussion is a technique that is central to participatory education. It allows members of a group to openly express their opinions on a subject, and listen to the opinions of others thus learning occurs through the interchange among members. Small groups of 4 to 5 participants are ideal. It is preferable to give the group a guideline so that discussion is focused.

2. Work pairsTwo participants can explore topics or issues that could be sensitive or of a very personal nature in a secure setting. Pair work is also appropriate for problem solving exercises that encourage intensive input, not consensus agreement. Remember to change pairs often so that the same two people do not always work together.

3. BrainstormingBrainstorming involves getting people to list all of the related ideas that they can think while someone records the ideas on paper without editing them. This technique helps participants to generate ideas quickly and fluidly while allowing them freedom to express any /all ideas. The advantage of working in groups is that the thoughts of one person may stimulate new directions of thought in another.

4. Role playA role – play is a simulation technique and involves a participant imitating or acting out a situation with members of the group. These members assume other roles related to learning objectives. Role-play allows participants to practice situations before they come across them in real life. It helps in sensitizing the participants to what may happen in a real situation.

5. Mini lectureThis is brief and well-paced lecture where definitions, facts or other information are presented to participants. The lecture should be presented verbally and should be visually supplemented by teaching aids such as information on flip charts, handouts, chalkboards, power point, transparencies etc. It should not last more than 10 minutes.

6. DemonstrationIn a demonstration, facilitators use examples, experiments, models or actual materials in order to illustrate a principle and show the participants how to carry out a certain activity. Demonstration provides concrete experiences of life-like situations. Demonstration improves practical skills and the ability to communicate with others. For example, using demonstration as a technique can be vital in educating participants how to use condoms.

7. Case studiesIt is a method of simulation, aiming to give experience in the sort of decision-making that the participants will have to do later. They are written based on real life events from existing sources of information such as newspapers, journals etc. Hence it is important to avoid over simplifying the case study since it would dilute the

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reality of the case. It would help the participants in self analysis if at the end of a case study the facilitator ends like this ‘we have considered the case presented to us and come to certain conclusions; now let us consider the case ourselves. How do we solve the problem ourselves?

8. Drill1. Gather the participants together and tell them you will conduct a drill. During the drill, they will review how to decide, for example, if a patient has presented with a set of symptoms, the participants may be asked to decide on whether the particular clinical presentation warrants a sputum examination. In a drill, as against an exercise, the answer to the questions is usually a one word answer. The participants may either give the answer aloud or they may be given appropriate placards, (eg. Yes / No), that they will have to display as their answer. Usually most of the participants will have the right answer. You may find a few with different answers. At this point ask the participants with the different answers to explain why they choose such answer and discuss. Continue the same procedure with the other triggers. This is a useful method that helps to recall what was taught in the just concluded session.

2. Explain the procedures for doing the drill. Tell participants:• This is not a test. The drill is an opportunity for participants to practise making this decision.

• You will call on individual participants one at a time to answer the questions. You will usually call on them in order, going around the table. If a participant cannot answer, go to the next person and ask the question again.

• Participants should wait to be called on and should be prepared to answer as quickly as they can. This will help keep the drill lively.

3. Ask if participants have any questions about how to do the drill.

4. Allow participants to review the text for a minute or two before the drill begins. Tell the participants they may refer to the text during the drill, but they should try to answer the question without looking.

5. Start the drill by asking the first question. Call on a particular participant to provide the answer. He should answer as quickly as he can. Then ask the next question and call on another participant to answer. If a participant gives an incorrect answer, ask the next participant if he can answer.

6. Keep the drill moving at a rapid pace. Repeat the list of questions or make up additional questions if you think participants need extra practice.

The drill ends when all the participants have had an opportunity to answer and when you feel the participants are answering with confidence.

9.Individual feedback to written exercisesWhen participants are working:

• Look available, interested and ready to help.

• Watch participants as they work and offer individual help if someone looks troubled or is not writing answers or turning pages (clues someone may need help).

• Encourage questions and requests for help.

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• If important issues or questions arise individually, make a note to discuss later with the entire group.

• If a question arises which you feel unable to answer adequately, obtain assistance as soon as possible from another facilitator or the Course Director.

• Written exercises can also be read aloud and discussed in the group.

10. ReadingWhen the facilitator manual says participants should read part of the manual or guideline, you can have participants read silently on their own, or ask for a volunteer to read a section in a loud, clear voice. Which method you choose depends on factors such as level of education of the group as a whole, differing levels within the group, their understanding of English, and what the group prefers. Make sure everyone is on the same page before beginning. If you are reading aloud, make sure that all participants who are willing, get chances to read during the course (do not force anyone). Sometimes it is helpful to ask someone to read who seems particularly sleepy or inattentive to wake them up. You mayalso choose a mixture of silent reading and reading aloud.

11. Explanations and lecturingAt times the facilitator is directed to explain certain important concepts. Explanations should be short and to the point, using the PowerPoint or a flipchart and/or referring to the manual. Avoid lecturing as this is not an effective way to learn. Occasionally, when pressed for time, it may be feasible to present certain material as a short, interactive lecture, rather than having participants read through a number of pages themselves, but this should not be the norm.

12. EnergizersAsk individual participants to be responsible for a few exercises or songs during the course of each day to make things livelier when attention is lagging or when people are tired but the day is not over. This should be decided as part of “housekeeping” activities at the start of each day. The facilitators should also have some energizers of their own to offer.

The “Jigsaw Puzzle” is included as an essential activity to be used in between sessions. This puzzle relates to the issue about “stigma & discrimination”. Divide the participants into 4 or 5 smaller groups. Give each of the groups one set of the puzzle pieces. The group that first puts together the puzzle is the winning group and will get a prize (Ensure that you have arranged for a small prize beforehand…eg. chocolates…etc). Once the puzzle is completed, brainstorm about the causes and effects of stigma & discrimination.

13. Role-Play in Training Sessions Facilitator InstructionsBefore the session:

1. Meet with the designated /volunteered participants and review the case study. Clarify how the “patient” participant (or facilitator) will present his/her case and what information they will provide from their health, personal/social, and treatment history. Clarify the specific role of the “doctor” participant. Clarify doubts if any. Practice role-play. Repeat practice until both are comfortable with it.

2. Ask the participants how he/she would like to be introduced to the students. Note details.

3. Confirm details of role play-time, place, etc.

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During training session:

1. 1Introduce the designated /volunteered participants to the students as per his/her instructions.

2. Set up the role-play in the front of the room and ensure that everyone will be able to hear the entire role-play.

3. Ask your co-facilitator to time the exercise and to give you a two-minute warning at 10 minutes so you will have time to complete the most important learning objectives of the exercise.

4. At the end of the role play ask the student participants “what was done well?” “what was not done well?”. Discuss.

14. Pre and post test Explain to participants that the purpose of the pretest is to give facilitators a sense of baseline knowledge of the group, and is not an evaluation. Allow 20-30 minutes for the test of approximately 30 questions. Decide beforehand if test should be anonymous (in which case participants will not know their scores) and what, if any, feedback will be given on test results. Do not discuss answers to the questions when test is finished, as the same test will be given as the post test, but explain that all material will be covered in the course. At least two persons should score the test on the same day it is given so that facilitators can gear each course to the level of knowledge of participants.

15. Evaluation of the trainingIt is important to see that the participants give a feedback of the workshop that is conducted. This is needed to assess the strengths and weaknesses of the training sessions. Hence there should be time set aside in the schedule of the workshop. Various aspects of the workshop and of the module itself have been considered in the evaluation tool given in Annexure.

16. Closing the workshopClose the workshop with a wrap up debriefing, songs, tea, distribution of certificates, and an oral feedback from a representative of the participants.

17. After the training workshopClassroom training is the first step. Participants would need to be supported by providing them information in the form a participant’s module, contact numbers or addresses of facilitators or of one person who would be responsible for providing follow-up support of the participants.

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Tuberculosis (TB) is a major public health problem in India. India accounts for one-fourth of the global TB incident cases. Each year nearly 2 million people in India develop TB, of which around 0.87 million are infectious. It is estimated that annually around 2.76 lakh Indians die due to TB that suggests that nearly 900 persons die every day of TB!

1. Introduction Facilitators Manual

Tuberculosis is a disease caused by the bacteria Mycobacterium tuberculosis (M. Tb). It is spread by airborne transmission. Any individual can be infected, and an individual infected with M. Tb has a 10% life time risk to develop active TB disease.

Figure 1.1: India accounts for more than one-fourth of the global TB burden

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Estimates of TB Burden in India and Global, 2017*

*India TB Report 2017

4%

HIV Posi�ve HIV Neg��ve

96%

4% of all TB

patients are HIV positive.(India TB Report 2017)

Co-infection with HIV or any immuno-deficient condition increases this risk. More than 80% TB affects the lungs. Of these about 50% are sputum smear positive and are infectious. The best way to control TB is by early detection and cure of infectious pulmonary TB cases.

HIV prevalence among incident TB patients is estimated to be 4.0%. It is estimated that 87,000 HIV associated TB patients are emerging annually. Hence, the TB epidemic in India continues to be predominantly driven by the pool of HIV negative TB infected individuals.

Tuberculosis is the most common opportunistic infection amongst HIV-infected individuals. It is a major cause of mortality among patients with HIV and poses a risk throughout the course of HIV disease, even after successful initiation of antiretroviral therapy (ART). By numbers India ranks 2nd in the world and accounts for about 10% of the global burden of HIV-associated TB

TB is a serious public health problem causing immense morbidity, mortality and distress to individuals, families and communities. TB kills more adults in India than any other infectious disease. The disease incidence peaks in people belonging to the most economically productive age group of 15-60 years.

Figure 1.3: Estimated number of deaths from HIV/AIDS and TB in 2017

In India, >1000 persons die every year

from Tuberculosis(1-2 TB patients die every other

minute)

In SummaryIndia accounts for one-fourth of the global TB burden

2 .7million people in India develop TB each yearClose to 50% are infectious cases

Tuberculosis is still a major public health problem

TB

HIV/AIDS

0 0.5 1 1.5Millions (2015)

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Milions 2017

Figure 1.2

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2. Diagnosis of Pulmonary Tuberculosis in Adults

Facilitators Manual

Missed opportunities for earlier detection of tuberculosis leads to increased disease severity for the patients and a greater likelihood of transmission of M. tuberculosis to family members and others in the community.

Session Duration: 60 minutesMaterials: Whiteboard, sputum cups, RNTCP sputum requisition formsLesson Plan: Session 2: Diagnosis of Pulmonary Tuberculosis No. Content Methodology Materials Duration

1 Clinical features of Presumptive PTB

Interactive, Ppt,Group Exercise.

Participant manual, white board.

5 min

2Select relevant investigations to confirm PTB

Interactive, Ppt. Participant manual, white board.

5 min

3 Sputum collection Role play. Participants manual, sputum cups,

15 min

4Interpretation of sputum smear microscopy report

Group Exercise. Participants manual. 5 min

5 Use of diagnostic algorithm

Case scenarios/ Exercise use of diagnostic algorithm.

Participants manual, copy of diagnostic algorithm.

25 min

6 Extra pulmonary TB Group Exercise. Participants manual. 5 min

Session objectivesAt the end of the session the participants will be able to:

• List features of presumptive pulmonary Tuberculosis

• Select relevant investigations to confirm pulmonary Tuberculosis

• Instruct the patient on appropriate sputum collection

• Identify radiological features suggestive of Tb on chest x ray

• Apply the diagnostic algorithm in common clinical situations

Would you presume tuberculosis in Ms Meena? Yes / No / Not Sure

What specific feature(s) makes you presume TB? Which symptom is the commonest seen in an adult with Pulmonary TB?

...........................................................................................................................................................................................

..........................................................................................................................................................................................

...........................................................................................................................................................................................

2.1 Case Scenario

Ms Meena, 25-year-old homemaker, visits your clinic with complaints of cough of 2 weeks duration. She does not have any fever, night sweats or weight loss and does not give history of hemoptysis

TOG 13

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The commonest symptom of PTB is persistent cough. This is usually of a duration two weeks or more, and productive with expectoration, sometimes with hemoptysis. Persistent cough may be accompanied by other symptoms such as fever, night sweats, anorexia, weight loss, chest pain or shortness of breath.

The lung is affected by TB in more than 80% of cases. This form of disease is called Pulmonary Tuberculosis (PTB). As TB spreads mainly by droplet infection, close contacts of a sputum smear positive PTB patient can get infected. Evidence suggests that by focusing on persons with persistent cough, the chances of identifying pulmonary tuberculosis are maximized. Detection of the most infectious cases of tuberculosis, i.e. sputum smear-positive pulmonary cases, by case-finding in patients attending health facilities is an essential component of the control of tuberculosis.

Treatment of those infectious patients rapidly renders them noninfectious, thereby cutting the chain of transmission. Failure to do sputum smear microscopy all persons with persistent cough are missed opportunities that have led to late detection, increased disease severity and a greater likelihood to transmission to family members and even the community. Thus, all persons with cough for 2 weeks or more, with or without other symptoms suggestive of TB, should be promptly identified as presumptive PTB.

Presumptive pulmonary Tuberculosis refers to a person with any of the symptoms and signs suggestive of TB including cough >2 weeks, fever >2 weeks, significant weight loss, hemoptysis and any abnormality in chest radiograph.

However, in HIV infected individuals or close contacts or children, cough of any duration should be investigated for tuberculosis. In these patients CBNAAT should be used.

Every person with any of the following such as, cough > 2 weeks, fever > 2 weeks, haemoptysis, significant weight loss, or any abnormality on chest

radiograph should be identified and investigated as a presumptive TB patient.

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2.2 Case Scenario

Exercise 2.1Individually tick the correct response column for each of the following case histories tabulated below:

Sl. No. Case Scenario

Suspicion of Pulmonary TB

YES / NOComments if any

115 year old girl with recurrent episodes of sneezing and runny nose / stuffy nose since 2 months.

NoNo fever, no cough, recurrent episodes looks like allergy

2 32 year male with fever, night sweats since 2 months. Yes Fever more than two weeks

353 year male, chronic smoker, presents with weight loss, cough and hemoptysis since 3 weeks.

YesCough more than 2weeks, hemoptysis, weight loss

427 year female with recurrent episodes of cough and difficult breathing associated with wheeze over a period of 2 years.

YesRecurrent episodes,wheeze, possible asthma

5 37 year male with fever, throat pain and cough since 7 days. No Fever & cough<7days,

6 50 year old male, diabetic with weight loss of > 5 kg Yes Significant weight loss

Ms Meena, 25-year-old homemaker, visits your clinic with complaints of cough of 2 weeks duration. She does not have any fever, night sweats or weight loss. Since there is more than 2 weeks of persistent cough, we now have identified a presumptive TB patient.

TOG 14

What essential investigations would you order to diagnose PTB?

Sputum smear microscopy & Chest Radigraphy

Every person with “presumptive TB” should have 2 sputum microbiological examination and Chest X ray done

At least one sputum specimen should be an early morning sample, as sputum collected at this time has the highest yield.

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How many sputum samples would you require?

One / Two / Three / Four?

What time of the day should she collect her sputum samples?

Spot collection / early morning sample / Day time / Before sleeping at night?

What instructions would you give to enable her to generate adequate sputum for specimens?

.......................................................................................................................................................................................

......................................................................................................................................................................................

Where would you send her or her sputum samples for microscopy?

To your nearest DMC

2.3 Case Scenario

Now Ms Meena is identified as a case of presumptive Tuberculosis and you have decided upon sputum microbiological tests to detect TB bacilli and need to instruct her on collection of her samples. TOG

14

Remember to counsel Meena about the disease and ask her to report back to you with sputum report to prevent primary defaulting.

Microbiological confirmation on sputum microscopyAll patients (adults, adolescents, and children who are capable of producing sputum) with presumptive pulmonary TB should undergo quality-assured sputum test for rapid diagnosis of TB (with at least two samples, including one early morning sample for microbiological confirmation. Instruction to generate sputum•The patient is asked to inhale deeply 2-3 times with mouth open, cough out deeply from the chest, open the labeled wide mouth container, spit out the sputum into it and close the container tightly• Sputum should be collected in the open air or in a vacant room with open windows•No one should be standing in front of the patient during this sputum collection •The patient may need to try again if only saliva is brought out• If the patient is unable to bring out sputum, sputum can be induced with 3% Saline nebulizationCollecting sputum for sputum microbiological examination•Care provider needs to fill in the “RNTCP Request Form for examination of biological specimen for TB” (15 (a) annexure Form) completely for sputum collection•Given one of the sputum cups, the patient is instructed to collect sputum then and there at the clinic / health center. This collection should be always be attempted in a well-ventilated area (outdoors would be ideal). The sputum cup/container should be closed tightly. This specimen is called a spot specimen.•For the next day, the patient is given a second similarly marked sputum container to collect an early morning specimen on the next day or two that needs to be delivered to the laboratory. This specimen is called an early morning specimen.

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2.4 Case Scenario

Ms Meena has clinical features of PTB. Her sputum result is given below. Kindly interpret the report and mention your next steps.

Microscopy ZN Florescent

Lab Sr. No

Visual appearance

ResultNegative Scanty 1+ 2+ 3+

Sample A 2331 S NegativeSample B 2456 S Negative

Date tested: 24.06.18 Date reported: 24.06.18 Reported by:

(Name & Signature)

Interpretation of Smear report: Negative

TOG 134

2.5 Case Scenario

On repeating the sputum examination ensuring the sputum collected is a mucoid sample and also an early morning sample, the following report was given. Kindly interpret the report and mention your next steps.

Interpretation of Smear report: positive

......................................................................................................................................................................


Lab Sr. No

Visual appearance


Sample A 2458 M NegativeSample B 2459 M Positive ++


(Name & Signature)

If the specimen cannot be sent to the lab immediately, store the sputum sample in a refrigerator or in another cool place. Sputum samples should be transported

and examined as soon as possible and not later than two days after collection.

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Figure 2.1: Diagnostic Algorithm for Pulmonary TB TOG 16

*Risk factors for (DR) TB• Failed treatment with first line drugs• Pediatric non-responders• TB patients who are contacts of MDR-TB (or R-resistance)• TB patients who are found positive on any follow-up sputum smear examination during treatment with first line drugs• diagnosed TB patients with prior history of anti-TB treatment• TB patients with HIV co-infection • All presumptive TB cases among PLHIV.

Based on the above algorithm what is your classification for Ms Meena?

Microbiologically confirmed TB?.................................................................................................Yes/ No/ Not clear

Microbiologically confirmed Rif sensitive TB?............................................................................Yes/ No/ Not clear

Non-TB?..........................................................................................................................................Yes/ No/ Not clear

One specimen positive out of the two is enough to declare a patient as Sputum Positive Pulmonary TB

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Exercise 2.2

Mentioned below are some case scenarios. Discuss and write what your next step would be for each of the scenarios.

Sl No Case Your next step

1Mr. Raja has presented with fever and cough of 3 weeks duration. Both sputum samples were reported negative for TB bacilli. Chest X ray is suggestive of TB.

CBNAAT -Microbiological confirmation of TB.

2

Mr. Mohan has fever, weight loss and cough of 3 weeks duration and comes to your clinic. Both sputum smears were negative. and chest radiograph is suggestive of tuberculosis He has a past history of TB.

CBNAAT-as (risk factor - previous treatment)Microbiological confirmation of TB & to assess drug resistance

Is HIV testing indicated in all patients with TB?All patients diagnosed with Tuberculosis, should undergo HIV counseling and testing. In addition, for HIV infected persons an antibiotic trial is not indicated if smears are negative. They should undergo further sputum testing like CBNAAT.

For additional details on HIV-TB co-infection kindly refer to the TOG page no 67.

1. Most common symptom of PTB is cough of two weeks or more, fever of two weeks or more, haemoptysis, and weight loss

2. All efforts have to be made to microbiologically confirm tuberculosis in these presumptive cases.

3. Elicit past history of ATT, risk factor of HIV & DM in all presumptive cases, offer CBNAAT testing in HIV positive, presumptive MDR cases

Take home message

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Extra Pulmonary TuberculosisPresumptive Extra Pulmonary TB refers to the presence of organ specific symptoms and signs like swelling of lymph node, pain and swelling in joints, neck stiffness, disorientation, etc and/or constitutional symptoms like significant weight loss, persistent fever for >2 weeks, night sweats.

Exercise 2.3

Mentioned below are some case scenarios. Discuss and write what your next step would be for each of the scenarios.

Sl No Case Your next step

1

Madan presents with 2-3 weeks of fever and headache. He has started vomiting too.

Fever of 2 weeks is a presumptive TB.

Suspect TB meningitis because of headache.

Send CSF for microbiological confirmation/CBNAAT

2

Kalpana presents with a swelling in the neck for 3 weeks. Its painless. No history of fever or weight loss. on examination, two 3cm by 4 cm firm lymph nodes are palpable in the cervical area.

Presumptive lymph node TB.

Consider FNAC/ biopsy and send for CBNAAT also.

320-year-old Ashwin presents with fever of 15 days with sharp pleuritic pain in the right side of his chest.

Suspect TB pleural effusion.

Confirm with XRAY and fluid analysis including CBNAAT

TOG 17

1. High level of clinical suspicion is important for diagnosis

2. CBNAAT to be offered upfront in sample obtained from EP sites in all presumptive case.

Take home message

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TOG 13

TOG 25

Case Definitions of Presumptive TB

Presumptive Pulmonary TB refers to a person with any of the symptoms and signs suggestive of TB including cough >2 weeks, fever >2 weeks, significant weight loss, hemoptysis, any abnormality in chest radiograph

Note: In addition, contacts of microbiologically confirmed TB patients, PLHIV, diabetics, malnourished, cancer patients, patients on immunosuppressants or steroid should be regularly screened for sign and symptom of TB

Presumptive Extra Pulmonary TB refers to the presence of organ specific symptoms and signs like swelling of lymph node, pain and swelling in joints, neck stiffness, disorientation, etc and/or constitutional symptoms like significant weight loss, persistent fever for >2 weeks, night sweats.

Presumptive pediatric TB refers to children with persistent fever and/or cough for more than 2 weeks, loss of weight*/no weight gain and/or history of contact with infectious TB cases***History of unexplained weight loss or no weight gain in the past 3 months; loss of weight is defined as loss of more than 5% body weight as compared to highest weight recorded in last 3 months**In a symptomatic child, with a person with any form of active TB with in last 2 years may be significant

Presumptive DR TB refers to those TB patients who have failed treatment with first line drugs, pediatric TB non responders, TB patients who are contacts of DR-TB (or Rif resistance), TB patients who are found positive on any follow-up sputum smear examination during treatment with first line drugs, previously treated TB cases, TB patients with HIV co-infection

Vulnerable Groups in whom TB –screening is recommendedClinical Social Geographical

Patients attending HIV care centre Prisoners Urban slums

Substance abuse including smoking Occupations with risk of developing TB

Hard to reach areas

Co-morbidities like Diabetes Mellitus, Malignancies, patients on dialysis and on long term immunosuppressive therapy

People in congregated settings : night shelters, de-addiction centers, old age homes

Indigenous and tribal populations

Health care workersHousehold and workplace contactsPatients with past history of TBMalnourishedAntenatal mothers attending antenatal clinics / MCH clinics

3. Classification Initiation of ATTFacilitators Manual

Session ObjectivesAt the end of the session, the participant should be able to:

Classification of TB for Initiation of ATT

• Classify TB- based on anatomical site of disease, based on history of treatment and based on Drug Resistance

• Initiate TB treatment- Identify and appropriately prescribe the correct regimen of ATT

• List steps to be completed for TB treatment initiation-Understand the rationale of Intensive and Continuation Phase

• List special populations and explain the importance of identifying this group

• Identify & discuss barriers to TB treatment adherence Assess and support for adherence

• List special populations and explain the importance of identifying this group

Adherence Preparation

At the end of the session, the participant should be able to:

• Educatepatientondrugside-effectsandprecautions

• Identifycommonobstaclestoadherence

• Suggestsolutionsforthesecommonobstacles

Referral

• To enumerate the indications for referral to a higher center

Treatment for tuberculosis is not only a matter of individual health-it is also a matter of public health. Thus, all providers, public and private, who undertake to treat a patient with tuberculosis, must have the knowledge to prescribe a standard treatment regimen and the means to assess adherence to the regimen and address poor adherence to ensure that treatment is completed.

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Session Duration: 75 minutesMaterials: Black/whiteboard, Drug boxesLesson Plan: Session 3: Initiation of ATTNo. Content Methodology Materials Duration

Classification & Categorization1 Classify TB Group work /Exercise. 5 min2 To appropriately prescribe ATT Case Scenario. 5 min3 Special Situations Interactive lecture. 5 min4 Categorization of TB Group work, Exercise. 15 min

Adherence Preparation 5 Adherence Interactive, PowerPoint. 56 Adherence counselling Role Play. Table/chairs, Check list 15 min7 Side-effects and precautions Interactive, PowerPoint. 10 min8 Obstacles & Solutions Interactive, discussion. Blackboard 10 min9 Referral Interactive, discussion. 5 min

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A diagnosis of TB should be followed by a classification of the type of TB (based on given Case Definitions), which is necessary for deciding appropriate treatment regimens and also for recording and reporting.Patients with TB infection are classified according to the anatomical site of disease, history of previous treatment, based on drug resistance, and based on whether the diagnosis was microbiologically confirmed or clinically diagnosed.1. Classification: Anatomical site of diseaseThe two main forms of TB based on anatomical site of disease are: a. Pulmonary TB (PTB): Disease affecting the lung parenchyma irrespective of any other site involvement. b. Extrapulmonary TB (EPTB): Disease not affecting the lung parenchyma AND affecting sites other than lung parenchyma, such as, lymph nodes, Pleura, meninges, pericardia, bone & joints, intestine, genitourinary tract, spine, skin, …etc. A patient with both Pulmonary TB and Extra-pulmonary sites is thus classified as Pulmonary TB and the extra-pulmonary site is recorded. 2. Classification: History of previous treatmentAt the time of registration, each patient is also classified according to whether or not he or she has previously received TB treatment. If the patient has received treatment previously, the case is classified based on the outcome of that treatment. It is important to identify previously treated patients because they are at increased risk of drug resistance including MDRTB3. Classification based on drug resistance: At the time of registration, each patient is also classified according to whether or not he or she has resistance to any of the Anti-tuberculous drugs.Mono-Resistance: A TB patient, whose biological specimen is resistant to one first line Anti-TB drug only.Poly-drug resistance: A TB patient, whose biological specimen is resistant to more than one first line Anti-TB drug, other than both Rifampicin and INH.Multidrug Resistance: A TB patient, whose biological specimen is resistant to both Rifampicin and INH, with or without resistance to other first line drugs.Rifampicin Resistance: Resistance to Rifampicin detected by phenotypic or genotypic methods, with or without resistance to other Anti-TB drugs excluding INH. Patients who have Rifampicin Resistance, should also be managed as MDR-TB case.

TOG 30

Disease Classification3.1 Case Scenario

Ms. Meena presented with cough of 2 weeks duration. Her physician performed sputum smear examination on her. One out of two smears is positive.

Using the given algorithm how would you classify Meena’s disease?

Sputum smear positive, new case

Exercise 3.1: Discuss within your groups and categorize the following patients

CaseMicro- biologically

confirmed/ clinically diagnosed

PTB/EPTB

New/ Previously

treated

Mono/poly/multidrug resistant

1. Mr. Chandhan,35 year old presents with 3 weeks of cough and breathlessness. His CXR showed right pleural effusion and sputum was positive for AFB. He has never been treated for TB before

Microbiologically confirmed

PTB New Not Available

2. Ms. Nyong, with history of previous treatment for lymph node TB one year ago, presents with cough and streaky hemoptysis. Her sputum CB-NAAT is positive for MTB and shows RIF resistance


PTB Previously Treated

MDR

3. Ms. Syeda, 36 yrs lady, had defaulted twice on ATT previously, presented with 2 months of cough and weight loss. Her sputum and CBNAAT was positive for MTB, and RIF resistance not detected, and culture showed resistance to Isoniazid only


PTB Previously treated

Mono

4. Mr. Nirmal Rai, 26 year old presents with one month of evening rise of temperature and exertional breathlessness. His CXR showed minimal effusion which was not amenable for a diagnostic tap. His symptoms did not subside after a course of antibiotic. His room-mate is on treatment for pulmonary TB.

Clinically confirmed

EPTB New Not available

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The decision on whether treatment can be initiated or whether the patient will need to be referred is based on: (a) drug sensitivity pattern and (b) history of previous anti-TB treatment.

History of Treatment Drug susceptibility status Type of regimen Action to be

takenNew Drug susceptible or Sent

for DST / CBNAATRegimen for new case Treat

Previously treated Drug susceptible or Sent for DST / CBNAAT

Regimen for previously treated case

Treat if drug sensitive

New or previously treated Drug Resistant Regimen based on DST Refer

TOG 31

3.2 Case ScenarioMs Christina who has recently been diagnosed to have sputum positive pulmonary TB one week ago comes to you for initiation of ATT. She has received Anti-TB treatment for one month previously. Her CBNAAT has been reported as Rifampicin resistance detected. How will you proceed further to manage this patient?Using the table below, explain that this is a case of previously treated TB and currently diagnosed as MDR TB.

Tuberculosis is classified into microbiologically confirmed Vs clinically diagnosed; pulmonary and extra pulmonary TB based on anatomical site;

new and previously treated based on history of previous treatment; and based on drug resistance.

Ms. Meena presented with cough of 2 weeks duration. Her physician performed sputum smear examination on her. One out of two smears is positive. Using the content below, discuss the importance of intensive phase & continuation phase in the treatment of TB

Intensive and Continuation PhaseThe goal of tuberculosis treatment is to ensure relapse-free cure while preventing the emergence of drug resistance

Treatment is given in two phases: Intensive Phase (IP) and Continuation Phase (CP).

Rationale for intensive phase: Historically, monotherapy led to high treatment failure and relapse rates. Initial administration of more than one drug, particularly a three- or four-drug regimen, greatly improves the efficacy of treatment. At least two bactericidal drugs, such as isoniazid and streptomycin or isoniazid and rifampicin, are required in the initial phase. Pyrazinamide given in the initial intensive phase allows a reduction in treatment duration from 9 to 6 months. Ethambutol is of benefit when initial drug resistance may be present or if the burden of organisms is high.

The Intensive phase is not extended beyond two months, even if the sputum smear is positive at the end of IP.

Rationale for Continuation phase

The continuation phase eliminates most residual bacilli and reduces failures and relapses. At the start of the continuation phase, numbers of bacilli are low and there is less chance of selecting drug-resistant mutants: fewer drugs are therefore needed. Hence Pyrazinamide is stopped and CP is with isoniazid, rifampicin and ethambutol.

The following table gives the regimen to be followed for treatment of TB:

The treatment of TB (other than confirmed Drug Resistant forms of TB) with daily regimen is to administer daily fixed dose combinations of first-line Anti-tuberculosis drugs in appropriate weight bands.

For treatment purpose, patients are categorized into New and Previously treatedTreatment is divided into Intensive phase and Continuation phase

Treatment is daily regimen and supervised throughout

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3.3 Case Scenario

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Type of TB Case Treatment regimen in IP Treatment regimen in CP

New (2) HRZE (4) HRE

Previously treated (2) HRZES+ (1) HRZE (5) HRE

Number parenthesis denotes duration of treatment in months.

Dosage for Drug-sensitive TB:

Weight CategoryNumber of tablets (FDCs)

Inj. StreptomycinIntensive phase Continuation phaseHRZE HRE

75/150/400/275 75/150/275 gm25-39 kg 2 2 0.540-54 kg 3 3 0.7555-69 kg 4 4 1>= 70kg 5 5 1• Drugs are available as fixed dose combinations and also in individual packs(each drug as a separate tablet)• Inj. Streptomycin to be added in IP phase for 2 months in the previously treated regimen of drug sensitive patients. In patients above 50 years of age, maximum dose of streptomycin should be 0.75 gm.

3.4 Case Scenario

Ms Meena is to be initiated on New Treatment regimen. Her body weight is 49 kilograms.What would be the recommended dose of ATT for her?

Medication and Packaging

TOG 38

Figure 3.1: Patient flow in case of patients diagnosed with TB

Counselling TB patients and family members

Educate about preventing spread-cough hygiene, proper disposal of sputum, screen contacts

Educate about disease and treatment and initiate treatment

Screen for comorbidities-Diabetes, liver and renal and neurological diseases and HIV

Screen for alcohol and tobacco (smoking) abuse

Counsel patient & family members about treatment monitoring & adherence: Monitoring progress till treatment completion, consequences of irregular treatment or premature discontinuation

Notify the patient, plan for continued monitoring and support during therapy

TOG 42

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Special population3.5 Case Scenario

3.6 Case Scenario

While initiating ATT you realize that Ms Meena is 3 months pregnant.

Are there any Anti-TB drugs to be avoided during pregnancy?

Streptomycin has to be avoided during pregnancy. All the other drugs can be given during pregnancy

Sheshadri, a 45 year old , is referred to you with a diagnosis of TB meningitis and has never received Anti-TB treatment before. What is your chosen Treatment? Is there any differences regarding duration of medication?

SHRZ should be given. Total duration of treatment can be extended from 3 to six months. Steroids are recommended if there is no suspicion of drug resistance

TOG 62

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TOG 56

It is important to keep in mind the special populations, when managing TB.Table 3.4: Special situations

Special Scenario Special IssuePregnancy All first line ATT drugs, except Streptomycin, can be used safely in pregnancy.

Streptomycin causes fetal oto-toxicity hence deafness.

Lactation All first line ATT drugs can be used safely during lactation. Breast feeding should be continued and mother should practice cough hygiene. Baby should be administered chemoprophylaxis as per guidelines. Baby should be given pyridoxine at 5 mg / kg

Paediatric TB Pediatric patient wise boxes are available in all DOT centers.

HIV TB is the commonest opportunistic infection and trigger for IRIS in HIV infected individuals. Due to drug interactions, Nevirapine should be avoided in patients receiving Rifampicin. TB in HIV infected persons is an indication for initiation of ART within 2-8 weeks of starting Anti-TB Treatment.

Liver disease Patients with an underlying liver disease need to be started on first line ATT cautiously with frequent monitoring of liver function tests. Those patients who develop ATT induced hepatitis could be in life threatening danger and always need to be referred for management and modified ATT.

Renal failure Streptomycin should be avoided in patients with renal failure because of reduced excretion leads to toxic concentrations that lead to oto- and nephro-toxicity. No changes are required in Isoniazid and Rifampicin dosing as they are excreted through bile. Pyrazinamide and Ethambutol doses should be modified according to Creatinine clearance.

Diabetes mellitus The drug regimen is same as in non-diabetic patients. Strict control of blood glucose is required. Also, doses of oral hypoglycemic agents may have to be increased due to interaction with rifampicin.

Substance Abuse Smoking is associated with an increased risk of TB related mortality and morbidity. Alcohol may potentiate liver related toxicity of ATT drugs. Substance abuse may also interfere with adherence and cure. Patients especially on anti-TB treatment should refrain from smoking and alcohol.

Hospitalization The vast majority of patients can be treated on an ambulatory basis. Indications for hospitalization are complicated pulmonary (pneumothorax, frequent hemoptysis, massive pleural effusion, those requiring surgical intervention) and serious extra-pulmonary disease (Meningitis, Adrenal insufficiency, Arthritis, etc.).

*Refer to manual page 56 in the TOG

Certain special Forms of EPTB like TB meningitis, TB Osteomyelitis and TB Arthritis need to be treated for longer duration given the serious risk of disability, mortality and difficulties of assessing response.

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Exercise 3.2: Categorization

No Case Scenario

Micro- biologically confirmed/ clinically

diagnosed

PTB/EPTB

New/ Previously

treated category

Mono/poly/multidrug resistant

1. Mr. Zaheer has cough for last 6 months with weight loss of 10 kgs. On examination you have found him to have generalised lymph-adenopathy. Chest X-Ray is suggestive of Miliary TB; Induced sputum specimens are positive for AFB; and, a FNAC of lymph nodes showing necrotising granulomatous lesion with 2+ AFB. He has never received Anti-TB treatment before.


PTB New Not Available

2. Mr. Mohan presented with fever, weight loss and cough of 3 weeks duration. Both smears and CBNAAT were negative. His doctor ordered for chest x-ray as per RNTCP protocol and x-ray revealed extensive parenchymal infiltrations suggestive of TB. He has never received Anti-TB treatment before.

Clinically confirmed

PTB New Clinically diagnosed PTB.Start on ATT

3. Ms.Anitha presented with 3 weeks of cough. Both smears were negative. Her chest x-ray revealed parenchymal infiltrations suggestive of TB. Sputum CBNAAT was reported as MTB detected, Rifampicin resistant.


PTB New RR-Drug resistant

4. Mr. Hariharan presented with cough and fever 8 months back. Based on a positive smear patient was started on ATT 8 months ago. He took treatment for 3 months and stopped all treatment after that as the symptoms subsided. He has now come to your clinic with recurrence of cough. His repeat sputum is positive.


PTB Loss to follow up

Start ATT as per previously treated regimen

Exercise 3.3: Categorization

No Case Scenario

Micro- biologically confirmed/ clinically

diagnosed

PTB/EPTB

New/ Relapse/ lost to follow-

up/ failure

Transfer yes/No

1. Mr. Anirudh has newly diagnosed sputum positive PTB. He is on DOTS for the last 3 months. He relocates to another city and continues DOTS in the new place.


PTB New Yes

2. Miss Begum Salah has been on DOTS (Sputum positive PTB) for the last 6 months and is still sputum positive at the end of therapy.


PTB Failure NA

3. Mr Chintala has EPTB (TB Lymphadenitis) and is put on DOTS. He takes his medications only for 45 days and returns to his home town in another state and stops ATT.

Not applicable EPTB Lost to follow up NA

5 Mrs. Elda received DOTS for PTB for 4 months and discontinued treatment. 6 months later, she is found to be sputum smear positive.


PTB Lost to follow up NA

6 Mr. Farhan had PTB in 2008 and completed a full course of DOTS having been declared cured. Two years later he was diagnosed to have sputum smear positive PTB.


PTB Relapse NA

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Adherence PreparationTOG

44At the end of the session, the participant should be able to:

• Educate patient on drug side-effects and precautions

• Identify common obstacles to adherence

• Suggest solutions for these common obstacles

Referral• To enumerate the indications for referral to a higher center

What is adherence to treatment?Adherence to treatment is following the recommended course of treatment by taking all the prescribed medications for the entire length of time necessary

TB is nearly always curable if patients adhere to their TB treatment regimen

Nonadherence is the patient’s inability or refusal to take TB drugs as prescribed

Adherence is very crucial in management of TB because of 3 important reasons:• To cure the disease in the individual patient• To minimize community spread • To prevent emergence of drug resistance.

Mr. Mohan with pulmonary TB has approached you for treatment.

How do you counsel him regarding strict adherence to treatment? List all you need to explain to him so that he understands and will adhere.

3.7a Case Scenario

You need to explain to Mr. Mohan the following:• Treatmentevenifsymptomaticallybetterorcontinuedsymptoms:

� Adherence � Regular dosing � Total duration is at least 6 months

• CombinationmedicationsnecessaryinTB � Multiple drugs taken together in combination

• Benefitsofcompletingtreatmentsuccessfully � Cure � Improved productivity � Prevention of spread to family members and community

• Risksofincompleteandnon-adherencetreatment � No cure � Development of Resistance to drugs � Spread to other systems � Spread to family, work colleagues and friends

• Coughhygieneandsputumdisposal � Patient education on spread � Cough hygiene (No indiscriminate coughing, no spitting, cough etiquette by covering the mouth

while coughing or sneezing) � Sputum disposal

Mr. Mohan has been initiated on New Treatment Regimen, now complains of nausea in the morning.

To educate patient on side-effects and precautions regarding medications

3.7b Case Scenario

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What are all the possibilities of his new symptoms while recently being initiated on Anti-TB treatment for his

PTB?

1. Gastritis

2. ATT induced hepatitis

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To identify common obstacles to adherence and to suggest solutions for these common obstacles

In case of jaundice, ask them to immediately meet their doctor as stopping all anti-TB drugs may be important to avoid severe liver damage.

Table 3.5: Anti-TB treatment drug Side Effects

Symptom Drug (abbreviation)Gastrointestinal upset Any oral medicationItching Isoniazid (H) Burning in the hands and feet Isoniazid (H)Joint pains Pyrazinamide (Z)Impaired vision Ethambutol (E)Ringing in the ears Streptomycin (S)Oto-toxicity Streptomycin (S)Jaundice Isoniazid (H), Rifampicin (R), Pyrazinamide (Z)

Mr. Mohan is getting transferred to another city in 2 months. This city is at least 6 hours journey away from the present DOT center. He assures them that he will continue treatment.

3.7c Case Scenario

List out the possible obstacles to adherence and suggest practical solutions to these problems.

Refer to the table below & discuss

DOT SupervisionSupervised treatment, which may have to include direct observation of therapy (DOT), helps patients to take their drugs regularly and complete treatment, thus achieving cure and preventing the development of drug resistance. Supervision must be carried out in a context-specific and patient-sensitive manner,and is meant to ensure adherence. Depending on the local conditions, supervision may be undertaken at a health facility, in the workplace, in the community or at home. It should be provided by a treatment partner or treatment supporter who is acceptable to the patient and is trained and supervised by health services.

Exercise 3.4: Suggesting practical solutions to barriers/obstacles to adherence Obstacles Suggestions

1 Migration2 Lack of awareness 3 Side effects of drugs

4 Misconception that he is cured once he becomes asymptomatic

5 Substance abuse6 Lack of family support7 Social stigma8 Distance from DOT Center9 Cost of transport to DOT Center

10 Loss of daily wages

ReferralPatients with TB either on or not on Anti-TB treatment will require cross consultations to support the successful care and treatment towards achieving a cure. Knowing when to refer is an important element in good clinical practice.

Complicated co-morbidities are referred to a higher center. There may be a need for consult to modify drug, monitor not only drugs, adherence but also complications of the co-morbidities. Refer Ready Reckoner for drug interactions.

Conditions coexisting with TB requiring referral are:

� Renal Disease � Liver disease � HIV – TB coinfection � TB Meningitis, TB Bone/Joint

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1. Tuberculosis is classified into pulmonary (microbiologically confirmed & clinically diagnosed tuberculosis. and extrapulmonary (microbiologically confirmed and clinically diagnosed)2. Patients are categorized into two categories, New and Previously treated, not only for registration but to determine treatment regimens.3. Treatment consists of an Intensive phase and a Continuation phase.4. Strict adherence to treatment is very crucial in management of TB to cure the disease in individual patient, to minimize spread to family and community, and to prevent emergence of drug resistance.

Take home message

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4. Monitoring of ATT

Monitoring of treatment is crucial to identify expected responses to treatment. Patients should be monitored for deviations from expected improvement and adherence to promote good treatment outcomes

Session Objectives• Listtherelevantclinicalfeaturesandlaboratoryinvestigationstobemonitoredonfollow-up

• Assessadherenceobjectively

• Planascheduleoffollow-upbasedonbacteriologicalinvestigations

• Activelylook&manageforcommonside-effectsofanti-tuberculartreatment

• Planthecontinuedmanagementofpatientsaccordingtobacteriologicalresults

• Definetreatmentoutcomesanddescribethecriteriaforsame

Session Duration: 60 minutes

Materials: Black/whiteboard, participants workbook

Lesson Plan: Session 4: Monitoring of ATT

No. Content Methodology Materials Duration

1 Factors to be assessed on follow-up

Exercise,Group work.

Participants workbook 10

2 Assessment of adherence

Interactive ppt, discussion.


3 Planning a schedule of follow-up based on investigations

Interactive PPT, Drill,Group work.


4 Diagnose and manage common side-effects

Discussion,Drill.


5 To define outcomes of treatment and their management

Interactive PPT. Participants workbook 5

Facilitators Manual

Clinical Bacteriological X-RayFrequency Monthly a. 1 smear After intensive

phase (after 2 months)b. 1 smear at end of treatment

If required at any time point when clinically indicated

What to be evaluated

Symptom Reduction Sign- weight gain chest symptom improvement

If smear positive at any time point- perform DST

Long term follow up

After completion of treatment at end of 6, 12, 18 and 24 months

In presence of any symptoms smear/ culture to be done

Others investigations

HIV, DM control if applicable and monitor Side effects to ATT

improvement on follow-up

TOG 48

1. List relevant clinical features to be monitored on follow-up of TB and Anti-TB Treatment.

a) Assess weight gain, symptom relief.

b) Discuss the importance of symptom relief

2. List relevant investigations to be monitored on follow-up of TB and Anti-TB Treatment.

Discuss the table given below with the timeline

All patients on ATT must be assessed for improvement periodically.Assessment includes subjective monthly and objective testing by sputum smear examination at the end of two months & at the end of treatment.

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4.1 Case Scenario

Ms. Meena, a 25 - year old homemaker, was diagnosed with sputum-positive pulmonary tuberculosis when she presented with cough of 2 weeks duration. She was started on RNTCP New regimen and has completed 2 months of Intensive Phase treatment.

Factors to be assessed on follow-up

Relevant clinical features and laboratory investigations to assess

TOG 47

4.2 Case Scenario

Ms. Meena is on Anti-TB Treatment and she says that she is taking drugs regularly.

How do you assess her adherence objectively?

Discuss based on the following points

Methods of monitoring adherence objectively

1. Check the tuberculosis treatment card to see if all doses have been received by the patient during treatment

2. Do a “pill count”. Check the empty blister packs to see if number of tablets consumed equals the number of doses to be administered in that duration

3. Ask the color of the urine - rifampicin colours urine red

4. Enquire the patient whether she has missed any dose? How many doses has she missed in the past? When did she last miss a dose?

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How to assess adherence ?

Exercise 4.1 : Clinical Improvement and Adherence at end of Intensive PhaseIndividually tick the correct response column for each of the following case histories tabulated below

No. Case Scenario Continue treatment

No improvement further

evaluationComments if any

1

15 year old girl with reduction of cough and expectoration after 2 months on Anti-TB treatment.

Continue Treatment

NA If symptoms improving continue ATT

2 32 year male with no weight gain at 2 months on ATT.

Continue Treatment

If sputum negative look for other causes for wt loss/lack of weight gain

3

27 year female with no cough but recurrent episodes of hemoptysis and 3 kilograms weight loss

Needs evaluation Repeat imaging/sputum to be relooked for DRTB as she has wt loss.Look for other causes of wt loss &hemoptysis

4

37 year old male whose treatment card shows all doses have been completed after 6 months of treatment.

Sputum Microscopy

3Hemoptysis alone does not indicate active tuberculosis. Refer for evaluation and further management.

4.3 Case Scenario

Ms. Meena has come back to your OPD with her sputum microscopy report. Her results are displayed below:

How will you now manage ms, Meena

Her results are displayed below:

Needs evaluation for DR TB – Discuss various scenarios possible (Table 4.1)

To plan follow-up schedule based on bacteriological investigationsTOG

48


Lab Sr. No

Visual appearance


Sample A 2558 M Positive +

Sample B


(Name & Signature)

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- 37 -

Use the below sputum smear guide to determine further testing (and treatment):

Table 4.1: Flowchart to decide follow-up schedule of sputum examination

New PTB Patient

Sputum pre-treatment

Repeat sputum due

Repeat sputum result Action required

Positive /Negative 2nd month Negative Repeat sputum at end of 6 months

Positive Perform DST and refer for DR

Smear conversion provides reliable reassurance of response to treatment. If smear remains positive, at two months or later and continue treatment till DST report comes & refer if required

Objective testing by repeat sputum smear examination must be performed in allAt the end of 2 months and end of treatment, if smear remains positive, perform

DST.CBNAAT should not be used for follow up as it may remain positive for MTB for

long periods of time even in responders.

Exercise To recognize and immediately manage common side-effects of anti-tubercular treatment

Mr. Kannan , presents with vomiting, epigastric pain and anorexia after 4 weeks of treatment

1. What would you suspect?

Drug Induced Hepatitis/ gastritis

2. What investigations will you order?

LFT

3. How will you manage this patient?

Discuss the possibilities based on the table below.

Side effects of treatment can appear at any time during treatment. The below table describes side-effects according to symptoms, when they appear and severity. Severe and potential life-threatening side effects warrant stopping treatment, urgent diagnosis and referral.You would suspect hepatitis in this patient and order liver function tests. If impaired, stop medications and refer for evaluation

4.4 Case Scenario

TOG 168

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- 39 -

Table 4.2: Symptom-based approach to evaluate ADR

Symptom Drug(abbreviation) Action to be taken by HW Action to be taken by MO

Gastro-intestinal (Vomiting or epigastric discomfort)

Any oral medication

Reassure patient. Give drugs with less water and over a longer period of time (e.g. 20 minutes). Do not give drugs on an empty stomach If the above fails, refer to MO

Maintain hydrationConsider treatment with anti-emetics (e.g. domperidone) and proton pump inhibitors (eg. Omeprazole)

Itching/ Rash Isoniazid (and other drugs also)

Reassure patient if itchy with no or mild rash.If severe (mucosal involvement, exfoliative and extensive, systemic symptoms) then stop all drugs and refer patient to MO

Itching without rash or a mild rash � Continue treatment and give antihistamines

Itching with moderate to severe rash � Stop all drugs till symptoms subside � Treat with antihistamines � Patients with mucosal involvement, fever

and hypotension will require treatment with corticosteroids

� When the reaction subsides reintroduce drugs gradually

� introducing the next drugTingling/ burning/ numbness in the hands and feet

Isoniazid Refer to MO � Give pyridoxine 100 mg/day orally or parenterally until symptoms subside.

� Patients not responding to pyridoxine will require treatment with amitriptyline

Joint pains Pyrazinamide Reassure that it is a self-limiting condition. Encourage patients to increase intake of liquids.If severe, refer patient to MO for evaluation

� Give NSAIDs like paracetamol, Aspirin or ibuprofen and in severe cases Indomethacin for a week to 10 days

� In severe cases estimate serum uric acid levels � If uric acid levels are significantly raised treat

with NSAIDs and colchicine. Allopurinol is not effective

� In severe cases with normal or slightly elevated uric acid consider reduction of the dose of Pyrazinamide.

Impaired vision Ethambutol STOP Ethambutol, refer patient for evaluation

� Refer to ophthalmologist for evaluation � Impaired vision usually returns to normal within

a few weeks of stopping ethambutol.

Ringing in the ears Loss of hearing Dizziness and loss of balance

Streptomycin STOP Streptomycin, refer patient for evaluation

� Refer to ENT for opinion � As hearing loss is usually not reversible do not

restart Streptomycin

: Anorexia / Nausea / Vomiting / Jaundice

Isoniazid, Rifampicin or Pyrazinamide

STOP all anti Tb drugs, Refer patient for evaluation

� Rule out other causes of hepatitis � Do not restart treatment till symptoms resolve

and liver enzymes return to baseline levels � If liver enzymes cannot be performed wait for

2 weeks after jaundice has disappeared to restart treatment

� Restart treatment with one drug at a time starting with Rifampicin, Isoniazid, Pyrazinamide.

� In patients with severe disease in whom treatment cannot be stopped use a non- hepatotoxic regimen consisting of Streptomycin and Ethambutol

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If Jaundice develops, immediately STOP all anti-TB drugs and refer.

Exercise 4.3 : Side Effects Write the correct drugs responsible for the side-effect mentioned in column 1

Serial No. Side-effec t ATT Drug responsible Action

1 Burning of feet, numbness of fingers

2 Reduced appetite and persis-tent high colored urine

3 Dizziness, tendency to fall and tinnitus

4.5 Case Scenario

Ms. Meena has completed 6 months of New treatment regimen. Sputum specimen is negative at the end of treatment.

To Define Treatment Outcome

1. How will you define her outcome? Cure/Failure/lost to follow up? Cure2. When and how will you define “Cure”? Sputum smear/culture should be negative at the end of treatment3. How is this different from “treatment completed”? If Sputum smear is not done / not available

A patient initiated on ATT can have different outcomes and eight outcomes have been defined by the RNTCP for the purposes of continued management, documentation and research.

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Table 4.3: Definitions for outcomes of treatment

Terms Definitions

Cured Microbiologically confirmed TB patients at the beginning of treatment who was smear or culture negative at the end of the complete treatment.

Treatment Completed

A TB patient who completed treatment without evidence of failure or clinical deterioration BUT with no record to show that the smear or culture results of biological specimen in the last month of treatment was negative, either because test was not done or because result is unavailable.

Treatment success

TB patients either cured or treatment completed are accounted in treatment success.

Failure A TB patient whose biological specimen is positive by smear or culture at end of treatment.

Lost to follow up

A TB patient whose treatment was interrupted for 1 consecutive month or more.

Not evaluated

A TB patient for whom no treatment outcome is assigned. This includes former “Transfer out”

Rx Regimen changed

A TB patient who is on first line regimen and has been diagnosed as having DRTB and switched to drug resistant TB regimen prior to being declared as failed

Died A Patient who has died during the course of anti TB treatment

TOG 65

There are 8 possible outcomesEvery patient MUST have only one outcome of treatment

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5. Tuberculosis in childrenFacilitators Manual

Session objectives At the end of the session the participants will be able to:

• Describe the common clinical features of tuberculosis in children (pulmonary and extrapulmonary)

• Explain the differences between adult TB and pediatric TB

• Define a “contact” of TB

• Read mantoux test

• Describe special techniques for sputum collection

• Explain the importance CB NAAT in diagnosis of pediatric TB

• Apply the diagnostic algorithm in common clinical situations-INH & Chemoprophylaxis

Session Duration: 60 minutes

Materials: Black/whiteboard, participants workbook

Lesson Plan: Session 4: Monitoring of ATT

No. Content Methodology Materials Duration

1 Common clinical features in children

Group work,Interactive, PPT.

Participants workbook 5 min

2Differences between adult TB and Pediatric TB



3 Investigation in Pediatric TB



4 Contact TB & Mantoux reading

Exercise,Group work.


5 Special techniques for sputum collection

Interactive, PPT. Participants workbook 5 min

6Use pediatric TB algorithm

Exercise / case scenario,Group work, Interactive PPT

15 min

7 Extrapulmonary TB in Children

Interactive PPT 5 min

Ramu, 3 years old, presents with cough of 3 weeks duration. He weighs 8 kg against an expected weight of 14 kg.

Would you presume tuberculosis in Ramu? Yes / No / Not Sure

What are the differences between adult and pediatric TB symptoms?

Which specific symptoms make you presume TB in children?

Discuss as per the information given below

Unlike adult TB, symptoms are nonspecific, especially in infants and young children. The presentation in infants may be more acute, resembling acute severe pneumonia. Symptoms may overlap with other common illnesses like hyperactive airway disease. Hemoptysis and night sweats are uncommon. One should presume TB in children if the following symptoms are present, either alone or in combination.

Presumptive TB � Persistent fever >- 2 weeks without known cause

and/ or � Unremitting cough >- 2 weeks and / or � weight loss of 5% in 3 months/ or no weight gain

in past 3 months � History of contact with infectious TB cases. (In a

symptomatic child, contact with any form of active TB in last 2 years may be significant)

TB in children is a direct consequence of adult TB and is a good marker of current disease transmission in the community.

An adult with any form of active TB in close contact with the child over the past 2 years is known as contact.

Figure 5.1 : Pediatric TB accounts for 20-30% of total burden of TB

TOG 20

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5.1 Case Scenario

Why is TB more dangerous in children compared to adults?

Adult TB Pediatric TB

Infection rate when in contact with infectious TB 20% 40-70%

Life time risk of active disease 5-10% 20-40%

Risk of disseminated TB Low High

Risk of severe EPTB (TBM) Low High

Risk of death Low High Underlying malnutrition, measles, and HIV infection enhance the chances of infection, progression to active disease, dissemination and death.

5.2 Case Scenario

Now we have presumed TB in Ramu as he has got cough of more than 2 weeks and he is malnourished.

What investigations would you order to confirm TB in children?

Mantoux, chest X-ray & sputum AFB

What are the challenges you are likely to face in the diagnosis of TB?

No single test will give a diagnosis of TB in children.

1. Collection of sputum is challenging

2. Ped TB is generally Paucibacillary

TOG 20

- 44 -

No single test will give a diagnosis of TB in children. After a careful history (which includes history of contact), nutritional assessment and clinical examination, employment of following investigations would help in making a diagnosis of TB.• Mantoux test (Tuberculin Skin Test)• Chest X ray• Microbiological confirmation (microscopy for AFB, CBNAAT, mycobacterial culture)

Exercise 5.1 Which tests would you order for Ramu? Tick appropriate test. You can order more than one test.

Yes / No

What challenges do you foresee in ordering these tests in your setting?

Sputum microscopySputum CBNAATChest X rayMantoux testIGRA Serological tests

Collection of extra pulmonary specimensBody fluids (spinal, pleural, pericardial, synovial, ascitic, bone-marrow) should be aseptically collected in a sterile container by the physician using aspiration techniques or surgical procedures. Specimens should be transported to the laboratory as quickly as possible.

TissuesThe aseptically collected tissues are placed by the physician in sterile containers preferably without fixatives or preservatives. If the specimen is to be shipped, it should be protected from drying by adding sterile saline or ideally in selective Kirchner’s liquid medium and maintaining a temperature of 4-150C.

SwabsSwabs are always sub optimal specimens and not recommended for microscopy/culture/ CBNAAT because of risk of infection for specimen collector.

UrineEarly morning sample should be collected in 500 ml screw capped sterile containers.

Bronchial secretions

For bronchial secretions the minimum volume: 2- 5ml and bronchial alveolar lavage (BAL) the minimum volume of 20-50 ml. Trans-bronchial and other biopsies should be collected under sterile conditions and placed in 0.5-1.0 ml of sterile normal (0.9%) saline to prevent drying during transportation to the laboratory.

- 45 -

Serological testsThe government of India issued Gazette notification (vide 433E 7th June 2012) has banned the manufacture, importation, distribution and use of currently available commercial serological tests for diagnosing TB. These tests are not recommended for diagnosis of TB.

Mantoux test was done on Ramu on 25.8.17 at 1 pm.

What is the strength of solution to be used in Mantoux Testing?

2TU/0.1ml

When will you read Mantoux test? 24hours / 48 hours /72 hours / 96 hours

What do you measure? Erythema / induration

5.3 Case Scenario

TOG 158

Points to remember about Mantoux test � Strength of solution - 0.1ml of PPD (2 TU) � Reading to be done at 48-72 hours � Measure induration (not erythema) � Induration 10 mm or more suggests infection � In malnourished and HIV infected children an induration of >5 mm is significant � A positive mantoux test indicates infection, may not be confirm active disease � Do not use Mantoux in adults for TB diagnosis.

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Gastric Lavage

In children, who rarely produce sputum, the aspiration of the early morning (gastric content) may be used for TB diagnosis.

NOTE:

� Samples for culture should never be collected in formalin. � If histo-pathological examination is required, two samples should be collected. One in saline for

microbiological examination and one in formalin for histopathology. � No preservative should be used for any extra-pulmonary specimen for culture /CBNAAT.

- 47 -

Scenario Induration Significant: Yes /No Why?Ramu ,3 years 8 mm Yes Ramu is Malnourished and

5 mm is significantChandu, 5 years, no malnutrition 8 mm No In well nourished child > 10

mm is significant Mary, 8 years, Mx done with 5 TU 12 mm No > 2 TU gives false positive

mantoux

Drill 1: Mantoux test

Mother took Ramu to another doctor for second opinion. This doctor suggested an IGRA test.

Would you agree with second doctor? Yes/no

Is this better than Mantoux test? Yes/no

The sensitivity of IGRA is low and gives indeterminate results in children <5 years of age. A positive IGRA test, like Mantoux test, suggests infection and not active disease. WHO recommends against using IGRA in diagnosis of TB.

Chest X-ray in children Unlike adults , there are no characteristic cavitary lesions in children, however following radiological features are highly suggestive of TB

Hilar nodes Collapse/ consolidation Miliary mottling

Microbiological confirmationThe recommended investigation for confirmation of TB in a child is Microscopy / Culture/CBNAAT. Therefore proper collection and transport of appropriate specimens for microscopy and culture is extremely important.

Do you think microbiological confirmation in a child is a difficult task compared to adults?

Yes / No

List the difficulties Paucibacillary- collection is difficult

………………………………..……………………………..………………...................................…………………

Are you aware of any special techniques for sputum collection in children?

Induced sputum, gastric lavage

Microbiological confirmation is very challenging in young children, as TB is usually a paucibacillary disease (90%), meaning, yield of sputum microscopy is less likely. In addition, collecting an adequate sputum sample for microbiological diagnosis is yet another challenge, especially in children less than 5 years as they tend to swallow the sputum. However employment of certain special technics improves the yield of MTB.

1. Induced sputum: Induction of sputum with 3% hypertonic saline nebulization enhances the chances of MTB isolation by 20-25%. This procedure can be done safely in young children between 5-10 years. (Ref).

2. Gastric aspirate: In infants and toddlers who are unable to expectorate sputum, collection of gastric aspirate in early morning improves isolation of MTB. Collected Sputum and gastric aspirate samples should be sent for AFB smears and CBNAAT. Same samples can be used for mycobacterial cultures as well.

- 48 -

- 49 -

Exercise 5.2: Choose appropriate test and technique

Exercise 5.3: Use algorithm to solve following scenarios

Sputum Induced sputum

Gastric aspirate Test ordered

6 months old Anu yes CBNAAT/AFB

3 years old Ramu yes CBNAAT/AFB

12 year old, Suma sputum CBNAAT/AFB

Diagnostic algorithm for Pediatric Pulmonary TB

Persistent Fever >2wk, without a known cause and/orUnremitting Cough for >2w and /orWt loss of 5% in 3m or no wt gain in past 3 months

CBNAAT * (sputum) *IF CBNAAT is not readily available, smear microscopyshould be performed

MTB not detected OR Sputum not available

X-Ray and TSTMTB detected

Microbiologicallycon�rmed TB care

XRC highly suggestive CXR NS shadowsTST -ve

CXR NormalTST +ve

CXR NormalTST -ve

Gastric Aspirate/Induced Sputum for CBNAAT

Give course ofAntibiotics

Evaluate for EPTBRefer to expert

Look foralternate cause+ve -ve

Persistent shadowand symptoms

No other likely alternative diagnosisClinically Diagnosed TB case

Gastric Aspirate/Induced Sputum for CBNAAT

+ve -ve

Refer to expert forwork up of persistent

pneumonia

1. Though TB is paucibacillary in children, all efforts should be taken to get microbiological confirmation2. CBNAAT is done upfront in children as it has higher sensitivity compared to AFB smear and results can be obtained within 2 hours3. CBNAAT is available free of cost under RNTCP

Scenario CBNAAT/AFB Mantoux Chest Xray Diagnosis Action Treat/refer

Ramu Induced sputum CBNAAT Positive

Hilar Nodes Microbiologically confirmed

Treat

Anu Gastric aspirate positive


Treat/Refer

Suma Sputum AFB Positive Microbiologically confirmed

Treat

Joe Positive Hilar nodes Clinically Diagnosed

Treat

Jamuna Negative Miliary Clinically Diagnosed

Treat

Sameera Negative Non specific Course of antibiotic

Suhail Negative Positive Normal Look for EPTB & Refer

Joel Negative Negative Normal Alternate cause

TOG 21

- 50 -

Take home Message

- 51 -

5.4 Case Scenario

5.5 Case Scenario

A 2 year old kamal is suffering from fever of 15 days, persistent vomiting and irritability. He threw a generalized seizure last night and brought to hospital today. History of contact is not forthcoming. However on probing, mother reveals that grandfather has been coughing for the past 6 months and taking some medicines on alternate days in a primary health centre.

18 year old Raja presents with neck swelling. On examination, matted cervical nodes are found.

Would you suspect extra pulmonary TB in Kamal and Raja? Yes / no

Is EPTB more common in children compared to adults? Yes / no

How do we establish diagnosis of TB in Kamal and Meena?

Diagnosis of EPTB is more challenging as AFB load is smaller compared to PTB and therefore isolation of AFB is difficult. CB NAAT should be done as an additional test along with other investigations like sugar, cells, protein and AFB stain.

In TB lymphadenitis, FNAC and histopathology will show granulomas. CBNAAT is done on same samples. Sensitivity of CBNAAT is found to be around 80% in CSF and FNAC samples. However, sensitivity is very low in pleural samples. Depending on the site, one may order imaging studies like USG, CT scan and MRI.

Like PTB, EPTB is classified as microbiologically confirmed/ clinically diagnosed.

Tuberculosis affects the lungs in 80% of the adult patients. Extra-pulmonary TB accounts for 15-20% of tuberculosis in adults and 30-40% in children. In HIV coinfection, incidence is much higher. (40-50%). One needs to evaluate all patients with EPTB for concurrent pulmonary TB. Patients who have both pulmonary and extra-pulmonary TB are classified as having pulmonary tuberculosis.

The common extrapulmonary sites of TB are:

TBM is the most severe among all EPTB sites

� Lymphnodes � Pleural effusion � Meningitis � Abdominal � Spinal TB with or without neurological involvement � Joints and Bones � Genito-urinary � Pericarditis � Peritonitis

Presumptive EPTB patient

Diagnostic Algorithm for Extra Pulmonary TB

Available

CBNAAT

If CBNAAT is not availableLiquid Culture

Appropriate specimen from siteNot Available

High Clinical suspicion

MTB detectedMTB not*derected

Rifsensitive

RifIndeterminate

RifResistant

MicrobiologicallyCon�rmed EPTB

Repeat CBNAAT onfresh specimen

Refer to management of Rif resitance

Indeterminate on 2nd specimen, collectfresh sample for Liquid Culture

Culture Positive Culture Negative

No TB

Use otherdiagnostic

tools

ClinicallyDiagnosed TB

AlternatediagnosisMicrobiologically

Con�rmed EPTB

* if high clinical suspicion then followhigh clinical suspicion �ow diagram

Sensitivity of CB NAAT on different samplesUsing the composite gold standard, the sensitivity in samples from children (86.9%) tended to be higher than that in samples from adults (77.6%).

Sample Sensitivity Sputum smear +ve 99%Sputum smear -ve 70.3%FNAC/Lymph node 88%Tissue Biopsy 95%Gastric aspirate 78%CSF 85%Pus 87%Pericardial/synovial/ascetic fluid 50%Pleural fluid 40%

*Lawn SD, Zumla AI. Diagnosis of extrapulmonary tuberculosis using the Xpert® MTB/RIF assay. Expert review of anti-infective therapy. 2012;10(6):631-635. doi:10.1586/eri.12.43.

TOG 19

- 52 -

- 53 -

Treatment of pediatric tuberculosis

Principles and duration of treatment are similar to that of adults. Dose is dependent on body weight, and different weight bands are available starting from 5 kg onwards. Follow up is more clinical in children though repeat AFB smears should be obtained whenever possible with special technics like induced sputum and gastric aspirate as discussed earlier.

Drug dosage in children

Drug Dosage mg/kg/dayIsoniazid 10mg/kg (7-15 mg/kg)

Rifampicin 15mg/kg (10- 20 mg/kg)

Pyrazinamide 30mg/kg (30 -40 mg/kg)

Ethambutol 20mg/kg (15 -20 mg/kg)

Streptomycin 15 mg/kg

FDC Dosage for pediatric tuberculosis

Weight category

Number of tablets (FDCs) Inj streptomycinIntensive phase Continuation phase

HRZ E HRE50/75/150 100 50/75/100 mg

4-7kgs 1 1 1 1008-11kgs 2 2 2 15012-15kgs 3 3 3 20016-24kgs 4 4 4 30025-29kgs 3+1A* 3 3+1A* 40030-39kgs 2+2A* 2 2+2A* 500

Would you like to treat Kamal yourself or refer to pediatrician?Indications for referral to a pediatrician or an expert • Onevaluation,foundtohaveonlyMantouxpositive• Nonspecificradiologicalfindings• SevereformsofEPTBlikemeningitis• Beforeachildisstartedonthe“PreviouslyTreated”regimen

� EPTB accounts for 15-20% of tuberculosis in adults & 30- 40% in children. � TB lymphadenitis and pleural effusion are the common forms of EPTB � TB meningitis is a serious form of EPTB � A high degree of clinical suspicion is a pre-requisite when a patient presents with suggestive symptoms. � The choice of investigation will depend on the site of EPTB. � CBNAAT to be used as an initial investigation whenever possible.

- 54 -

6. Contact Screening and Chemoprophylaxis

Facilitators Manual

6.1 Case Scenario

Mrs. Meena is diagnosed as microbiologically confirmed pulmonary tuberculosis. She has been started on “New” treatment regimen. She has a 3-year-old child Munna.

Would you like to screen Munna for tuberculosis?

Yes

All providers should ensure that persons in close contact with patients who have infectious tuberculosis are evaluated and managed. Though it is ideal to screen everyone who is living in close contact, lack of adequate staff and resources makes contact investigation a challenging task.

The highest priority contacts for evaluation are:• Children aged <6 years

• Contacts with known or suspected immunocompromised states, particularly HIV infection

• Persons with symptoms suggestive of tuberculosis

• Contacts of patients with MDR/XDR tuberculosis

As discussed earlier:• Children, especially younger than 5 years, are more likely to acquire infection while in close contact with infectious TB.

• Children tend to develop serious EPTB disease like TB meningitis.

• People with HIV infection have a high risk for acquiring TB infection and rapidly progressing to active TB disease.

Hence these high-risk groups should be screened for symptoms as a priority. However any contact exhibiting symptoms of TB should be promptly evaluated irrespective of age and immune status. The main benefit of contact screening being, early detection of disease and prevention of transmission.Methods of screening include history, examination and appropriate investigations as discussed under sections on” diagnosis of adult TB” and pediatric TB “ .

TOG 52

- 55 -

Going back to child kamal with TBM ; His grand -father had history of TB.

Could we have prevented TBM in Kamal?

Yes

Yes; The treating doctor should have screened Kamal for active TB when grandfather was diagnosed, and started Kamal on either treatment or chemoprophylaxis (ref to algorithm below)

Chemoprophylaxis

• Children less than 6 years and HIV infected patients progress to active disease rapidly Hence these group of people should be screened for active disease and if found to have no active disease, should be initiated on INH prophylactic therapy.

• INH therapy reduces the risk of tuberculosis disease 90% in young children.

• Isoniazid, 10 mg /kg/day (maximum 300 mg) is given daily for six months.

TOG 52

6.2 Case Scenario

Chemoprophylaxis is indicated in the following groups in close contact with infectious TB

(After ruling out active infection)

� Children < 6 years

� People with HIV infection

Chemoprophylaxis

Treat According to category

Symptomatic

6H

Less than 6 years

Asymptomatic

Child hood contacts of smear positive cases

8-year-old Ramya was diagnosed with miliary TB. Parents deny any history of TB in the family.

However on evaluation, mother’s Chest X ray revealed extensive fibrocavitory lesions.

In case of paediatric TB patients, reverse contact tracing for search of any active TB case in the household of the child must be undertaken to prevent ongoing transmission.

Reverse contact tracing

6.3 Case Scenario

Child’s X Ray Mother’s X Ray

- 56 -

- 57 -

TOG 131Case Scenario

Ravi has recently diagnosed untreated sputum positive pulmonary disease. He needs admission to hospital for severe respiratory distress with hypoxia.

Q: Should he be admitted in an isolation ward?

A: Yes, if you have an isolation facility with good ventilation. Physically separating the patient from other patients is however not mandatory as only the sputum is infectious and not the patient. The patient should follow cough etiquette and appropriate sputum collection and disposal.

Q: Are the health care personnel at risk for infection?

A: There is negligible risk if infection control measures are in place. Daily exposure for prolonged periods over many days without infection control measures is required for disease transmission.

Q: What are the infection control measures for minimizing risk of transmission to other persons?

A: The most effective measure is early diagnosis and initiation of ATT under DOT. This prompt and timely action will make infectious TB patients rapidly non-infectious. It is now mandatory that any Infection Control plan of the facility should include infection control for TB and TB/HIV.

The measures include:

Administrative

� Effective implementation of RNTCP diagnostic and treatment guidelines in the health care facility

� Giving priority to patients with cough for clinical and laboratory investigations for early diagnosis.

� Reducing delay in starting appropriate RNTCP treatment.

� Avoiding unnecessary admission for inpatient care

� On site health care workers training under RNTCP at least once in 2 yrs.

� Sputum collection should ideally be done outside the facility and away from other people. It should not be done in closed areas such as toilets and in ill-ventilated rooms.

� Processing specimens for smear microscopy (after sputum collection) has not been documented to cause any increased risk to laboratory personnel.

Annexure AInfection Control

Facilitators Manual

� However, TB suspects amongst health care workers should be screened.

� Those who are symptomatic or/and with any signs of TB or Chest X-ray abnormality should be offered a CBNAAT testing at first instance and during periodic screening also

Environment

� Measures to reduce the generation and concentration of droplet nuclei in the air in high-risk areas. High- risk areas include relatively small, enclosed rooms in health facilities which lack adequate cross ventilation in the form of open windows and doors.

� Adequate daily cleaning of floor with soap and water and other surfaces with disinfectants .

� Educating the patients regarding cough hygiene (covering the face while coughing and avoiding indiscriminate spitting)

� Frequent identification of risk areas within the facility and providing good cross ventilation.

� Collecting all sputum in covered sputum cups. The sputum should be rendered non-infectious by immersing in 5% phenol with a standing time of 12 hrs. It is then discarded by flushing into a drain. Empty sputum cups, wooden applicators used for smear preparation to be autoclaved before disposal

Personal protection

� Wearing of surgical mask for personal protection does not protect personnel from inhaling the droplet aerosols and hence is not recommended.

� An Infection control plan for TB-HIV may include precautions to be observed for HIV in addition to those observed for TB, especially when streptomycin injections are being given. Disposable or adequately sterilized needles and syringes should be used for streptomycin injection. Following injection needles and syringes should be disposed using prevailing hospital waste management system.

� Health care workers can effectively prevent infections acquired through contaminated blood by the adoption of Standard Precautions..

The peripheral health institutions are responsible for proper disposal of biomedical waste and should report to their respective pollution control board. For further information on biomedical waste management kindly refer to www.tbcindia.org

- 58 -

� The key to reducing the risk of tuberculosis transmission at health facilities is early diagnosis and prompt initiation of DOTS

� Infectious TB patients become rapidly non-infectious once they are started on directly observed treatment

� Other safety measures include administrative, environmental and personal level initiatives at the health facility

- 59 -

1. What is TB notification?

Reporting about information on diagnosis &/or treatment of Tuberculosis cases to the nodal Public Health Authority or officials designated by them for this purpose.

2. Who is expected to notify TB cases?

Every healthcare provider meaning clinical establishments run or managed by the Government (including local authorities), private or NGO sectors and/or individual practitioners.

3. Are the public sector health facilities expected to notify the TB cases?

Yes. All Tuberculosis cases diagnosed &/or treated, whether under DOTS strategy or not, should be notified.

4. To whom should TB cases be notified?

Nodal Public Health Authority or officials designated by them for this purpose. State/UT & district-wise contact details are available on www.tbcindia.nic.in

5. When can TB cases be notified?

On diagnosis or initiation of anti-TB treatment of a Tuberculosis case. Such reporting to the nodal public health authority should be done at least on monthly basis.

6. How can TB cases be notified?

� Hard copy by post, courier or by hand to the nodal officer

� Soft copy by email from persons / institutes authorized for this purpose to the nodal officer

� Using authorized mobile numbers by phone call, IVRS or SMS *

� Uploading of information directly on to the Nikshay portal http://nikshay.gov.in

� Direct online information transmission from newer diagnostic machines like CB-NAAT or MGIT etc.

*Will be available in future

7. Why should private health facilities notify TB?

Notification gives an opportunity to support private sector for better practices in terms of Standard TB care which include helping the patients to get right diagnosis, treatment, follow up, contact tracing chemoprophylaxis & facilitates social support systems. Complete and accurate data obtained from notification will allow continuous evaluation of the trend of the disease with better estimation of burden/impact.

Annexure BTuberculosis notification in India Frequently Asked Questions

Facilitators Manual

8. How can I find out the contact details of the nodal officer for TB notification in my area?

The list of Nodal Officers is available on http://tbcindia.nic.in/.

In States/UTs or districts where the bilateral understanding is established between the Health Establishments and the local public health authorities for convenient local TB notification, the information on TB Notification can be submitted to the local public health authorities (e.g. Medical Officer of the Primary Health Centre) as designated by the district nodal authority for TB notification. However, this should be done only in consultation with the concerned district nodal officer for TB notification.

In case, health care provider is not aware about the contact details of the nodal officer for TB Notification in the district the same may be obtained from the respective District TB Officer / State TB Officer for the updated contact.

9. What do I do when I am unable to contact the nodal officer for TB Notification?

You may contact respective District TB Officer / State TB Officer. In case of any grievances, the same may be sent to [email protected] & issues regarding electronic reporting data update may be sent to [email protected] mentioning the name and complete address of the individual and the health care facility.

10. I am a medical practitioner but I neither diagnose nor treat TB cases. Do I still have to submit the TB notification report to the nodal officer?

Health establishments and medical practitioners not routinely diagnosing / treating TB patients may give an undertaking regarding the same while agreeing to submit the information in future, in case they diagnose or treat any TB case.

11. What is a TB case?

Microbiologically-confirmed TB case – Patient diagnosed with at least one clinical specimen positive for acid fast bacilli, or Culture-positive for Mycobacterium tuberculosis, or RNTCP-approved Rapid Diagnostic molecular test positive for tuberculosis

OR

Clinical TB case – Patient diagnosed clinically as tuberculosis, without microbiologic confirmation and initiated on anti-TB drugs.

12. What are the different types of TB cases?

New TB case – Patient who has never been treated with anti-TB drugs or has been treated with anti-TB drugs for less than one month from any source

Recurrent TB case – Patient who has been treated for tuberculosis in the past and been declared successfully treated (cured/treatment completed) at the end of their treatment regimen.

Treatment change – Patient returning after interruption, and patients put on a new treatment regimen and due to failure of the current treatment regimen.

- 60 -

13. How Site of disease can be defined for TB cases?

Pulmonary TB case – Patient with TB of the lungs (with or without involvement of any extra-pulmonary locations).

Extra-pulmonary TB case – Patient with TB of any organ other than the lungs, such as pleura, lymph notes, etc, diagnosed with microbiological, histological, radiological, or strong clinical evidence.

14. Which TB diagnostics are endorsed by RNTCP?

Smear Microscopy (for AFB) using Zeil-Nelson Staining or Fluorescence stains and examination under direct or indirect microscopy with or without LED.

Culture for MTB on Solid (Lowenstein Jansen) media or Liquid media (Middle Brook) using manual, semi-automatic or automatic machines e.g. Bactec, MGIT etc.

Rapid diagnostic molecular test for MTB using conventional PCR based Line Probe Assay for MTB complex or Real-time PCR based Nucleic Acid Amplification Test (NAAT) for MTB complex e.g. GeneXpert

Note: Diagnosis of TB based on radiology (e.g. X-ray) will be termed as clinical TB

15. What can be the Rifampicin resistance status of TB patient?

Rifampicin resistant – Patient with a drug susceptibility test result from a RNTCP-certified laboratory or WRD (WHO approved Rapid Diagnostic) drug susceptibility test report showing resistance to rifampicin.

Rifampicin sensitive – Patient with a drug susceptibility test result from a RNTCP-certified laboratory or WRD (WHO approved Rapid Diagnostic) drug susceptibility test report showing sensitivity to rifampicin.

Not available – Patient without a drug susceptibility test result from a RNTCP certified laboratory

16. What are the consequences of failing to notify a TB case?

As per MCI code of Ethics – Rules & regulations 2002, Chapter 7, Point 7.7, a registered medical practitioner giving incorrect information on his name and authority about Notification amounts to misconduct and such a medical practitioner is liable for deregistration.

17. Is it ethical to share the information about TB patient, as it is a professional secret between a doctor and his patient and needs to be kept confidential?

As per MCI code of Ethics – Rules & regulations 2002, Chapter 7, Point 7.14, it is the duty of the registered medical to divulge this information to the authorized notification official as regards communicable and notifiable diseases.

18. Is there a provision for punitive / legal action if I do not notify TB cases in Constitution / MCI rules?

Yes.

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19. How will the TB notification information be used by the National Programme / Government?

For undertaking Public Health measures like contact tracing of infectious cases, counselling support for treatment adherence and follow-up. Also, the surveillance system will be helpful in estimating the burden of TB disease in the country.

20. What if I notify a TB case and later on I found it not to be TB?

Information on such rare cases may be intimated to the nodal officer for TB notification

21. What will happen to the TB cases I have notified?

Support for treatment initiation, adherence, follow-up, default retrieval, contact tracing will be extended to such patients by public health staff. Though patient may opt to seek care from providers outside national TB control programme

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Annexure CRNTCP Request Form For exmination of biological specimen for TB

Facilitators Manual

RNTCP Request Form for examination of biological specimen for TB (Required for Diagnosis of TB, Drug Sensitivity Testing and follow up)

Patient InformationPatient name Age (in yrs):____ Gender: M F TGPatient mobile no. or other contact no.

Specimen date ofcollection(DD/MM/YY) _______

Sputum Other (specify)______Aadhar no.

Patient address with landmark

HIV Status: Reactive Non-Reactive UnknownKey populations:Contact of known TB Patient Diabetes Tobacco Prison Miner MigrantRefugee Urban slum Health-care workerOther(specify) ______

Reason for Testing:Diagnosis and follow up of TB

Diagnosis (NIKSHAY ID_________________) Follow up (Smear and culture)H/O anti TB Rx for >1 month: Yes No RNTCP TB Reg No ______________

NIKSHAY ID:________________Regimen: New Previously TreatedReason: End IP End CPPost treatment: 6m 12m 18m 24m

Presumptive TB Repeat Exam Private referral Presumptive NTM

Predominant symptom __________________

Duration ______ days

Diagnosis and follow up Drug-resistant TBDrug Susceptibility Testing (DST) Follow up (Culture)

Presumptive MDR TB

New Previously treated PMDT TB No ____________DR TB NIKSHAY ID: _______________Regimen: Regimen for INH mono/poly resistant TB Regimen for MDR/RR TB Shorter regimen* Modified Regimen for MDR/RR-TB + FQ /SLI resistance Regimen for XDR TB Modified Regimen for mixed pattern resistance Regimen with New Drug for MDR-TB Regimen + FQ/SLI resistance Regimen with New Drug for XDR-TB Regimen with New Drug for failures of regimen for MDR TB Regimen with New Drug for failures of regimen for XDR-TB Regimen with New Drug for mixed pattern resistanceTreatment Month Week :____________

At diagnosis Contact of MDR/RR TB Follow up Sm +ve Private referral Discordance resolution

Presumptive H mono/poly

Presumptive XDR TB

MDR/RR TB at Diagnosis ≥ 4 months culture positive 3 monthly for persistent culture positives (treatment month _____) Culture reversion Failure of MDR/RR-TB regimen Recurrent case of second line treatment Discordance resolution

Test requested: Microscopy TST IGRA Chest X-ray Cytopathology Histopathology CBNAAT CultureDST Line Probe Assay Gene Sequencing Other (Please Specify) ____________________Requestor Name, Designation and Signature: ________________________________________Contact Number:________________ Email ID:______________________Results: NIKSHAY ID Generated: ______________________ CDL NIKSHAY ID: _______________

Microscopy ( ZN Florescent)

Lab Sr. No Visual appearance ResultNegative Scanty 1+ 2+ 3+

Sample ASample B

Date tested: ______________ Date Reported:_______________ Reported by:______________________ (Name and Signature)

Name and Type of referring facility (PHI/DMC/TU/DTC/ICTC/ART/Medical College/DR-TB Centre/Private Others, specify): __________________________Health Establishment ID (NIKSHAY): _ _ _ _

CDL NIKSHAY ID: _ _ - _ _ _ - _ - C - _ _- _ _ _ _ _RNTCP TB Reg No. __________________ Or☐ Not Applicable

State: _____________________ District:_______________ Tuberculosis Unit (TU): _________________

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Topic Minutes

1. Introduction............................................................................................................................... 15

2. Diagnosis.................................................................................................................................. 60

3. Classification and Initiation of ATT.........................................................................................

�Disease Classification and Initiation of ATT................................................................... 30

�Adherence Preparation.................................................................................................... 30

�Referral............................................................................................................................ 15

4. Monitoring of Anti-Tuberculous Treatment.......................................................................... 60

5. Tuberculosis in Children....................................................................................................... 60

Based on TOG of RNTCP

Training Program Schedule

Annexure DTraining program schedule

Facilitators Manual

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Disclaimer: This document is made possible by the generous support of the American people through the United States Agency for International Development (USAID). The contents are the responsibility of St John’s Medical College, Bangalore and KHPT and do not necessarily reflect the views of USAID or the United States Government.

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