MDR-TB Module Report Guide
- Cordt Byrne
Available Reports
Reports
Drug Requirements Analysis
Details on Available Reports
PATIENT LISTS
View All Patient Lists
Generates a list of patients. List can be filtered by basic characteristics. Options available to control the data output.
Determining which patients are to be included in the list |
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Choose which data points to be included in the list. | Screenshots |
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There are three options to control the format of the output data: Basic Details, MDR-TB Short Summary, and Custom. |  |
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Active MDR-TB Patients
This links to the Patient List Generator, defaulted to only include patients currently enrolled in the MDR-TB Program. See above for details on the Patient List Generator.
Cohort Builder
Details on the Cohort Builder to come soon.
REPORTS
WHO Form 05
Quarterly report on MDR-TB detection and Category IV treatment start
1. Number of patients detected with MDR-TB/XDR-TB in the lab (by date of result of MDR-TB/XDR-TB in laboratory register) during the quarter.
Base cohort: All patients enrolled in MDR-TB program at reporting location with a DST result recorded during the quarter.
Poly-resistance (PDR-TB): Patients who had a DST result during the quarter that showed resistance to more than one antituberculosis drug, other than both isoniazid and rifampicin
Multidrug-resistance (MDR-TB): Patients who had a DST result during the quarter that showed resistance to isoniazid and rifampicin (but which did not meet the parameters for XDR-TB)
Extensive drug-resistance (XDR-TB): Patients who had a DST result during the quarter that showed resistance to any fluroquinolone, and at least one of three injectable second-line drugs (capreomycin, kanamycin and amikacin), in addition to multidrug-resistance.
2. Number of MDR-TB patients who started Category IV treatment during the quarter.
Base cohort: All patients enrolled in MDR-TB program at reporting location who started treatment on any tuberculosis regimen during the specified quarter
Columns:
All are calculated from the MDR-TB program workflow “Registration Group – Previous Drug Use”.
New Case: Patients who have received no, or less than one month, of anti-TB treatment, including patients with a DST ordered within one month of treatment start
Previously treated with first-line drugs: A patient who has been treated for one month or more for TB with only first-line drugs.
Previously treated with second-line drugs: A patient who has been treated for TB for one month or more with one or more second-line drugs.
Rows:
Calculated based on DST results.
Confirmed cases: Patients with confirmed MDR-TB (or XDR-TB), based on DST result. Poly-resistant patients should not be included in this category.
Suspected cases: Any other patient started on MDR-TB therapy, even those patients who were later found to be culture or DST negative and had their treatment stopped. WHO definition states that these patients should have been started only because representative DST surveys or other epidemiologic data indicate a high probability of MDR-TB.
Data quality checks:
Ensure that all patients with an intake form or lab result recorded have been enrolled in the MDR-TB program at a location.
Ensure that all DST results are up-to-date.
Ensure that initial drug regimens have been entered.
Ensure that the workflow state “Registration Group – Previous Drug Use” is up to date for all patients
WHO Form 06
Six month interim outcome assessment of confirmed MDR-TB cases (to be filled out 9 months after treatment start)
Base cohort: All patients enrolled in MDR-TB program at reporting location who started treatment on any tuberculosis regimen during the specified quarter
Columns
Number started on treatment: Total number of patients in the base cohort
Bacteriologic results at six months of treatment
Negative (smear and culture negative): Patients with at least one smear and culture, and no positive smears or cultures, during treatment months 5 and 6 (which are the 6th and 7th monhs of treatment based on the WHO standard of starting with treatment month 0)
Positive (smear and/or culture positive): Patients with at least one positive smear and/or culture during treatment months 5 and 6
Unknown: Patients with no positive smear or culture, but without both a negative smear and a negative culture during treatment months 5 and 6
No longer on treatment
Died: Patients who died within 6 months of treatment start ( patients with TREATMENT OUTCOME = PATIENT DIED during first 6 months of treatment)
Defaulted: Patients whose treatment was interrupted for two or more consecutive months for any reason without medical approval within 6 months of treatment start (patients with TREATMENT OUTCOME = PATIENT DEFAULTED during first 6 months of treament)
Transferred out: Patients who have been transferred to another facility during first 6 months of treatment ( patients with TREATMENT OUTCOME = TRANSFERRED OUT during first 6 months of treatment)
Other: Patients who had a treatment outcome other than died, defaulted, or transferred out during the first 6 months of treatment (normally, no patients should fall in this category)
Data quality checks:
Ensure that all patients with an intake form or lab result recorded have been enrolled in the MDR-TB program at a location.
Ensure that treatment start dates are correct.
Ensure that all smear and culture results have been entered.
Ensure that patient outcomes are up to date (and that outcome dates are correct).
Check for suspected defaulters who have not had outcome updated (look for patients without an encounter in the last two months)
WHO Form 07
Annual report of treatment result of confirmed MDR-TB patients starting Category IV treatment (to be filled in 24 and 36 months past the closing date of year of treatment)
Base cohort: All patients enrolled in MDR-TB program at reporting location who started treatment on any tuberculosis regimen during the specified year
Columns:
All are calculated based on workflow TREATMENT OUTCOME
Cured: Patients who have completed treatment and have at least five consecutive negative cultures from samples collected at least 30 days apart in the final 12 months of treatment. Doctors may mark a patient as cured if only one of the cultures is positive, but it is followed by three consecutive negative cultures and there is no concomitant clinical evidence of deterioration.
Treatment completed: Patients who have completed treatment but do not meet the definition of cured, eg who do not have at least five cultures taken in the final twelve months.
Failed: Patients for whom two or more of the final five cultures are positive, or if any one of the final three cultures is positive, or for whom treatment has been terminated early.
Defaulted: Patients whose treatment was interrupted for two or more consecutive months for any reason without medical approval.
Died: Patients who died for any reason.
Transferred Out: Patients who transferred to another facility.
Still on treatment: Patients who have not yet completed treatment (that is, have no TREATMENT OUTCOME set).
Total: Total of all of the above. This group should exclude the following patients:
Patients whose DST did not meet the criteria of multidrug-resistance, and whose Category IV treatment was therefore cancelled (TREATMENT OUTCOME = DRUG SENSITIVE)
Patients whose outcome is unknown due to loss of paper files, and who could not be contacted (TREATMENT OUTCOME = LOST TO FOLLOWUP)
Rows:
All are calculated based on the MDR-TB program workflow “CLASSIFICATION ACCORDING TO PREVIOUS DRUG USE”. See definitions in WHO Form 05 section.
New
Previously treated with first-line drugs only
Previously treated with both first- and second-line drugs.
Data Quality Checks:
Ensure that all patients with an intake form or lab result recorded have been enrolled in the MDR-TB program at a location.
Ensure that treatment start dates are correct.
Ensure that all smear and culture results have been entered and that conversion status is correct.
Ensure that patient outcomes are up to date (and that outcome dates are correct).
Check for patients who meet the criteria of “Cured”, “Completed”, “Failed” and “Defaulted” but are not set to that state, and vice versa
Check for patients who do not have a PREVIOUS DRUG USE status.
Outcome Report
Report on patient outcomes by Category IV registration group for patients who started treatment during a given time period
Base cohort: All patients enrolled in MDR-TB program at reporting location who started treatment on any tuberculosis regimen during the specified year (and quarter/month if specified).
Columns:
All are calculated based on workflow TREATMENT OUTCOME
Cured: Patients who have completed treatment and have at least five consecutive negative cultures from samples collected at least 30 days apart in the final 12 months of treatment. Doctors may mark a patient as cured if only one of the cultures is positive, but it is followed by three consecutive negative cultures and there is no concomitant clinical evidence of deterioration.
Treatment completed: Patients who have completed treatment but do not meet the definition of cured, eg who do not have at least five cultures taken in the final twelve months.
Failed: Patients for whom two or more of the final five cultures are positive, or if any one of the final three cultures is positive, or for whom treatment has been terminated early.
Defaulted: Patients whose treatment was interrupted for two or more consecutive months for any reason without medical approval.
Died: Patients who died for any reason.
Transferred Out: Patients who transferred to another facility.
Still on treatment: Patients who have not yet completed treatment (that is, have no TREATMENT OUTCOME set).
Total: Total of all of the above. This group should exclude the following patients:
Patients whose outcome is unknown due to loss of paper files, and who could not be contacted (TREATMENT OUTCOME = LOST TO FOLLOWUP)
Rows:
All are calculated from the MDR-TB program workflow “Registration Group – Previous Treatment”.
New: The patient has never received treatment, or if the patient has received less than one month of treatment at the time of collection of the sputum sample that was used to confirm MDR-TB.
Relapse: The patient previously completed treatment, and the outcome of the previous treatment was “cured” or “treatment completed”.
After Defaulted: Patients who are returning to treatment following an interruption of treatment for two or more consecutive months.
After failure of Category I Treatment: The patient failed treatment after taking RHEZ
After failure of Category II Treatment: The patient failed treatment after taking second line drugs.
Transferred In: The patient is transferring from another site where they were taking Category IV treatment.
Other: Patients who do not fit into any of the given categories.
Unknown
Total
MDR-TB Indicator Report
Report on MDR-TB treatment to be completed monthly and quarterly
Diagnosis / Treatment and Follow-up of MDR-TB Patients
1.a Number of patients hospitalized for MDR-TB treatment - Newly Hospitalized: Patients who were hospitalized during the reporting period. Hospitalization information is pulled from the Hospitalization section on the Overview tab.
1.b Number of patients hospitalized for MDR-TB treatment - Total Hospitalized: Patients who had been hospitalized at any point.
2.a Number of new patients who started treatment for MDR-TB - Smear Positive: Positive smear at any point during the reporting period.
2.b Number of new patients who started treatment for MDR-TB - Smear Negative:
2.c Number of new patients who started treatment for MDR-TB - Total:
3. Number of patients who have abandoned treatment: Program outcome of “PATIENT DEFAULTED”
4. Number of patients who have died: Pulls from program outcome.
5. Number of new MDR-TB patients who are HIV positive: Where do we enter this?
6. Number of patients referred-in for MDR-TB evaluation: Patients with Registration Group – Previous Treatments is “TRANSFER”
7. Number of patients with negative control smear: Most recent smear, within the reporting period, is negative.
8. Number of patients with positive control smear: Most recent smear, within the reporting period, is positive.
9. Number of patients with positive diagnostic culture: First culture on record is positive.
10. Number of new patients with tests that confirm multi-drug resistance: Resistant to at least isoniazid and rifampcin.
11. Number of patients that are in treatment but not hospitalized: Not hospitalized at any point during the reporting period.
12. Number of patients with a pending culture: What defines a pending culture. The patients returned in the report appear to have results for all their cultures.
13. Total Number of patients that are co-infected with MDR-TB and HIV: Patient Susan Yatuta shows up as co-infected, but in her chart the HIV status is unknown.
14. Number of positive control cultures: Most recent culture, within the reporting period, is positive.
15. Number of negative control cultures: Most recent culture, within the reporting period, is negative.
16. Number of patients who have successfully completed treatment for MDR-TB: Patients with programs that were completed during the reporting period with an outcome of TREATMENT COMPLETE or PATIENT CURED.
17. Number of patients who have failed treatment for MDR-TB: Patients with programs that were completed during the reporting period with an outcome of REGIMEN FAILURE.
18. Number of patients who have resumed treatment for MDR-TB during the month: ????
Distribution of patients according to their resistance pattern
Returns the number of patients with a particular resistance pattern, e.g. R+H+E+S.
Specimen Reports
Parameters: Specimen collection date (start date and end date) and testing facility. Also time frame in which we should expect culture results after a positive smear, and the time frame in which we should expect DST results after a positive culture results.
Output: All four sections list patient name, specimen collection date, and sample ID
Specimens with positive smear results but no culture results: Collected in specified date range, with no culture results after the specified number of days.
Specimens with positive culture results but no DST results: Collected in specified date range, with no DST results after the specified number of days.
Specimens reported as contaminated: Collected in specified date range.
Specimens with no test results: Collected in specified date range.
Resistance Profiles
Lists all patients who are resistant to at least one drug.
Base cohort: All patients actively enrolled in MDR-TB program resistant to at least one drug.
Output: Patients name, enrollment date, and resistance profile, e.g INH+R+H+S..
DRUG REQUIREMENTS ANALYSIS
Drug Usage
Parameters: Drug Group (e.g. TB Drugs), Date range (Beginning and End)
Average Daily Use: The daily usage of all medications active within the specified date range.
Total Quantity Required: The average daily usage multiplied by the number of days in the specified date range.
Price per unit: To be manually added.
Cost for this drug: Total quantity required multiplied by the price per unit.
Number of patients taking each drug
Returns the number of patients taking each drug on the day specified.