IPConnect

16. RECORDING AND REPORTING

16.1. Introduction

The information system for DR-TB is an extension of the TB information system and defines the minimum tools to monitor the management of DR-TB patients effectively. This information system allows the managers at different levels to monitor programme performance by following the distribution and trends in MDR-TB notification and treatment outcomes of patients started on Regimen IV. It does not include the detailed information that HCWs may need to manage individual patients, which is, however, contained in the patient clinical records and other forms used in the hospitals and clinics.

Particular attention must be paid to full documentation of patient particulars and every effort must be made to ensure that all patients are seen regularly by the management team during the treatment period to ensure a comprehensive management plan. The patient, facility records must be completed daily and updated monthly on the paper based and electronic DR-TB register (EDRWeb). Each hospital must have a person responsible for data management and compile case finding, case holding and treatment outcome reports.

16.2. Case Definitions for MDR-TB and XDR-TB

Case definitions for MDR- and XDR-TB are used to:

Allow proper patient registration and epidemiological notification;
Facilitate case allocation to appropriate treatment categories;
Facilitate case evaluation according to site, bacteriology and treatment history; and
Evaluate programme performance through cohort analyses.

A case of MDR-TB is defined as a patient with bacteriologically proven TB whose disease is due to bacilli showing in vitro resistance to rifampicin and isoniazid, with or without resistance to other first-line anti-TB drugs.

MDR-TB diagnosed through DST is also called “Confirmed MDR-TB”.

Not confirmed MDR-TB cases are patients commenced on MDR-TB treatment after a decision of a provincial DR-TB review committee or DR-TB practitioner on the basis of clinical presentation, radiological findings and medical history indicating a high probability of MDR-TB. It is worth noting that it is difficult to make a laboratory diagnosis of MDR-TB in children (see chapter 12).

Patients who have mono-resistance to rifampicin through GeneXpert or conventional DST will be registered as “not confirmed MDR-TB” because they receive MDR-TB treatment. These patients will later be changed to “confirmed MDR-TB” when laboratory confirmation becomes available.

A case of XDR-TB is defined as a patient with bacteriologically proven TB whose disease is due to bacilli showing in vitro MDR together with resistance to any fluoroquinolone plus resistance to one or more of the following injectable anti-TB drugs: kanamycin, amikacin, and capreomycin.

History of previous TB treatment allows categorisation of MDR and XDR-TB patients into three categories. These categories are essential for epidemiological monitoring of the DR-TB epidemic and help to identify patients that may be at risk. The patient categories are shown in the following table.

Site of disease is classified according to pulmonary or extra-pulmonary involvement:

Pulmonary MDR- and XDR-TB refer to disease involving the lung parenchyma only.
Extra-pulmonary MDR- and XDR-TB refer to organs other than the lungs.
A patient with both pulmonary and extra-pulmonary MDR- and XDR-TB constitutes a case of pulmonary MDR- and XDR-TB.
The case definition for extra-pulmonary MDR- and XDR-TB in several sites depends on the site with the most severe form of disease.

Severity of disease is classified according to bacteriological status (smear or culture, positive or negative) at diagnosis.

16.3. Data Collection Tools and Flow of Information

The DR-TB data collection tools are similar to the TB data tools; others are the same such as suspect register and the referral forms. This section describes the core set of tools that are used for patient management and surveillance.

16.3.1. DR-TB Treatment Card

HCWs administrating drugs daily to the patient must use this card to complete all the necessary demographic and management information about the patient. This card should be completed when a patient is started on DR-TB treatment and updated daily. It should remain in the MDR-TB hospital and a patient follow up card issued when the patient is discharged from the hospital, but must be updated monthly when the patient comes for follow up at the hospital.

The card contains the following sections:

Basic demographic information: Name, gender, age, at least two physical addresses (patient, next of kin or friend, work) as well contact details.
DR-TB register number and date of registration.
Previous tuberculosis treatment episodes: All TB episodes that the patient has had should be recorded here for both sensitive and resistant TB.
Previous medical history: History of any other medical condition for which the patient might be taking medication or previously took medication for as well as substance abuse must be recorded. This must include history of previous admission to a hospital, imprisonment and working in the mines.
Patient category: There are eight possible groups: new, relapse, treatment after default, treatment after failure of first treatment, treatment after failure of re-treatment, transfer in, and other (previously treated but the outcome is unknown).
Site of disease: The affected organ must be specified in patients with extra-pulmonary TB disease. The International Classification of Diseases (ICD 10) Codes should be used.
Drug resistance history: The number refers to whether it was a new, primary or re-treatment (after default/failure/relapse).
Regimen and doses: The initial treatment regimen is recorded on the treatment card, as well as any changes and adjustments in treatment.
Sputum results for microscopy and culture: Monthly monitoring of smear and culture is required. The date and results of any DST conducted are recorded on the treatment card.
Drug susceptibility results: The date and results of any DST conducted are recorded on the treatment card.
Record of daily administration of drugs: Each end every dose of oral or injectable drugs administered to the patient is recorded in this section.
Adverse drug reactions: Any ADR that the patient experiences are graded and recorded. Any drug adjustments, adjuvant therapy or additional drugs for the management of side effects must be recorded.
Clinical progress notes: Weight, laboratory test results and chest x-ray findings monitoring these items can be recorded on the treatment card in the monthly drug administration section in the last column.
Outcome of treatment: At the end of treatment the outcome should be recorded on the treatment card according to the outcome definitions.

16.3.2. DR-TB Treatment Follow-up Card

This card records the same information as the treatment card but when the patient is discharged from the hospital or referred to another hospital, s/he takes this card to the receiving facility. The health care worker at the clinic updates the information on the card daily during follow up care and the information on this card is used to update the hospital treatment card on a monthly basis. The receiving clinic should notify the hospital when patient arrives at the clinic by completing the referral acknowledgement slip and sending it back to the hospital or by facsimile or telephonic confirmation where possible.

16.3.3. DR-TB Register

This register records all patients who receive treatment for drug resistant TB including mono- and poly-resistance. It is used to monitor patient progress while on treatment and allows for evaluation of the programme through quarterly, six-monthly and annual analysis of case finding, culture conversion and treatment outcomes.

The registers must be kept in all MDR-TB hospitals (central and peripheral). The information from the patient treatment card is entered into the register and should be updated daily for new patients registered and monthly for smear and culture results and treatment outcomes.

All patients in whom DR-TB have been confirmed must be registered in the DR-TB register, even if they have not started treatment. The following is recorded in the DR-TB register:

DR-TB register number: This is a unique patient identification number for patients that enter DR-TB treatment.
Date registered.
Name, sex, date of birth, address.
District TB register number.
Site of disease: Pulmonary (vs) extra-pulmonary.
Registration category: There are eight possible groups – new, relapse, treatment after default, treatment after failure of first treatment, treatment after failure of re-treatment, transfer in, and other (previously treated but the outcome is unknown).
Second-line drugs already received: Yes or no.
DST: Date and results. Patients may have had more than one DST. The diagnostic DST (which resulted in the patient being registered as a MDR- or XDR-TB patient) is entered. The full DST history is recorded on the treatment card. Follow-up DST results are not recorded in the register.
Reason for being registered as DR-TB. Reasons include mono- or poly-resistant TB, confirmed or not confirmed MDR-TB, confirmed or not confirmed XDR-TB. If the patient is not started on treatment the reason is given in the subsequent column.
The DR-TB regimen: The date and the initial regimen are recorded.
Smear and culture monitoring results: Date and result.
Final outcomes: At the end of treatment the outcome should be recorded on the treatment card according to the outcome definitions.
Comments. This section is reserved for any additional information

16.3.4. Patient Identity Card

Once a patient is diagnosed with DR-TB, a patient identity card should be completed at the same time that the treatment card is completed, and be kept by the patient. The card contains the following:

Demographic details (name, age, sex, address).
DR-TB register number.
Registration group.
Essential treatment information (start date, regimen, ADRs, clinical progress).
Health centre where the patient will receive treatment.
Dates of appointments.

16.3.5. Request for Sputum Examination

The top of the form is identical to the form used in DOTS programmes, while the middle part is used for requesting culture and DST. The bottom part is used for reporting the results. The same form is returned to the treating unit with the results.

16.4. Treatment Outcome Definitions

The outcome definitions are based on bacteriological culture as a monitoring tool:

Cure: A patient who has converted (with 2 consecutive TB culture negative taken 30 days apart), and has remained TB culture negative, has completed treatment and has been consistently culture-negative for five consecutive months in the final twelve months of treatment. If one positive culture is reported during that time and there is no concomitant clinical evidence of deterioration, a patient may still be considered cured, provided that this positive culture is followed by a minimum of three consecutive negative cultures, taken at least thirty days apart. This outcome is restricted to confirmed pulmonary DR-TB patients.
Treatment completed: A patient who has completed treatment but does not meet the definition for cure due to lack of bacteriologic results (i.e. less than five cultures were performed in the final twelve months of treatment).
Death: A patient who dies from any cause while on DR-TB treatment.
Treatment default: A patient who interrupts DR-TB treatment for two or more consecutive months for any reason.
Treatment failure: A patient who has had two or more of the five consecutive cultures taken in the final twelve months and are positive, or if any one of the final three cultures are positive. Treatment failure may be observed in patients who do not respond to treatment after 6 to 8 months of effective treatment. Such patients will be put on a different treatment regimen after receiving an outcome of failure and be allocated to a new treatment cohort.
Transfer out: A patient who has been transferred to a reporting unit in another province and for whom the treatment outcome is unknown.
Treatment stopped due to ADRs: A patient who develops ADRs while on DR-TB and could not continue treatment in spite of the management of the ADRs as per protocols and the decision has been taken to stop treatment.
Treatment stopped due to other reasons; A patient who could not continue on DR-TB treatment for any other medical reason than ADRs, and a decision to stop treatment was made.
Still on treatment: A patient who for any reason is still on treatment at the time of submission of treatment outcome report.

16.5. Cohort Analysis of Treatment Outcome

Details of all patients identified with DR-TB should be recorded in the register. The register must clearly identify MDR/XDR-TB patients from those with other forms of drug resistance and those that are not confirmed MDR/XDR-TB.

An MDR/XDR-TB cohort is defined as a group of patients registered with MDR/XDR-TB during a specified time period (i.e., one year). The date of the diagnostic DST result and treatment start date should also be recorded in the register but it is the date on which the patient is registered that determines to which cohort the patient belongs. All diagnosed MDR/ XDR-TB patients should be offered treatment. If any patients are left untreated, the reasons for exclusion should be explicitly delineated. Some examples of reasons for exclusion from treatment include:

Died before treatment was initiated.
Patient unwilling/refuses treatment.
Drug supply shortage.
Limited health facility access.
Clinical reasons.
Social reasons.

Cohort analysis of treatment outcomes should be performed on all patients started on treatment DR-TB treatment, regardless of treatment duration. They should be stratified by the case registration groups; further sub-analysis of cohorts according to HIV status, history of previous second-line drug use, DST pattern, and regimen utilised is also useful.

The analysis of MDR/XDR-TB treatment outcomes should be performed 24 months after the last patient enrolment date in the cohort (interim outcome) and at 36 months (final outcome report) All patients should be assigned the first outcome they experience for recording and reporting purposes The analysis at 36 months will be directed at patients who were still on treatment after 24 months of treatment. There is no need to review outcomes of the entire cohort.

Patients still on treatment at the end of a designated cohort treatment period must also be explicitly identified as such, and whether they were culture-positive or negative at the time of the cohort analysis.

16.6. Quarterly Report of DR-TB Case Finding

The quarterly report is divided into five tables. The tables report the following information:

Table 1: Numbers of M/XDR-TB patients detected in the laboratory during the quarter.
Table 2: Numbers of Confirmed and not-confirmed M/XDR-TB cases started on treatment during the quarter.
Table 3: HIV and ART status of M/XDR-TB patients started on treatment during the quarter
Table 4: Proportion of MDR-TB detected, started on treatment and reasons for not starting treatment
Table 5: Proportion of XDR-TB detected, started on treatment and reasons for not starting treatment

This report is completed with a delay of one quarter, to allow for culture and DST results to be ready. For example, DR-TB patients registered during the first quarter of a year (01 January to 31 March) should be reported in the quarter 3 report. In this report the date when the patient first enters the DR-TB register (registration date) is used, and not the date when the patient starts DR- TB treatment.

Preliminary Six-month Interim Outcome Assessment Form

Each defined cohort should have an interim or preliminary outcome report. This report should be developed by the central DR-TB unit or the decentralised DR-TB unit. This report looks at the number of confirmed M/XDR-TB patients with a smear and/or TB culture negative by the sixth month of treatment. If there is no result at month 6, the fifth month result should be considered.

Annual Report of Treatment Outcome of DR-TB Cases

This report shows the final results of treatment by year of treatment started, for all cases as well as for cases stratified by smear and culture results and patient registration category.

Since treatment is of long duration, the results will reflect the management of treatment during a prolonged period in the past. To assess quicker changes in default, failure, deaths etc., optional forms for preliminary outcomes are also available. An electronic system will generate these reports much easier.