Decision point on minimum data for routine recording and reporting
- What data should be routinely captured and reported to the national level for programme management?
- What is the minimum dataset needed to monitor individual case management and monitor progress across the TPT pathway?
- What tools and methods should be used to facilitate data collection and reporting?
Monitoring and evaluation (M&E) play an important role in patient care and in assessing national programmes and global response (Fig. 8.1). Accurate recording and reporting of programmatic data informs managers about immediate outputs and outcomes of programme services, as well as the larger impact of resources invested into a programme. If services are adequately accessed, if key activities are occurring in a timely manner, and if expected results are achieved, then it is very likely that the overall goals will also be met. When running well, M&E should be able to provide health care providers and programme managers with information on how many contacts were in a TB patient’s household and how many of them were effectively evaluated. Or, how many people offered TPT in an ART clinic decided to take it, and how many of those starting TPT continued it until the end.
Monitoring programmatic implementation of TPT
As several activities under PMTPT – such as contact investigation and TB preventive care of People with HIV, overlap with screening for TB disease, and involve similar at-risk populations, M&E activities should be aligned to promote synergies and limit duplication. It is important to ensure that all individuals who are most at risk of developing TB are systematically identified, and once TB disease is excluded, offered TPT to improve both their individual health as well as community disease burden (some principles on how to estimate the numbers eligible for TPT are given in Box 8.1). Programmatic implementation and scale-up of TPT requires strengthening of each element in the cascade of care starting from identification of the target population to provision and continuation of TPT (Fig. 8.2).
# total number
* if chest radiography and IGRA or TST are not used, this would be the number without clinical evidence of TB disease; if chest radiography and IGRA or TST are available this would be the number without clinical or radiological evidence of disease +/- with positive test for TB infection
Indicators for monitoring of PMTPT
The generation of indicators is a critical endpoint for the process of recording and reporting. It is traditionally done every quarter at regional and national levels, depending on the number of people being monitored. Data on TPT services are aggregated at regular intervals and reported to higher levels for monitoring progress. If an electronic case-based data system is available with nationwide coverage, then aggregation may be done at lower levels at any required frequency to inform about programme performance.
While Table 8.1 represents a minimum set of PMTPT indicators, the programme may decide to monitor other activities, such as the coverage of testing for TB infection (TST/IGRA) among people targeted for testing as part of investigation of eligibility for TST.
Key point: Ministries of health and national programmes should integrate M&E for TPT into the existing national HMIS. Establishment of a parallel and stand-alone data collection and reporting system for PMTPT is not required or desirable.
Minimum individual level dataset for monitoring TPT
A minimum set of variables is proposed to be collected at the individual (case-based) level at three important instances for PMTPT
1. Assessment of contacts of TB patients
2. Assessment of People with HIV and other at-risk groups
3. Initiation and completion of TPT.
* Please see text and Table 5.3 for proposed thresholds of completion by regimen type.
Programmes may wish to collect additional data to review certain programmatic barriers, such as medication adherence. If drug safety cannot be satisfactorily monitored from routine pharmacovigilance systems, data on adverse drug reactions (frequency, organ class, severity/seriousness and response to withdrawal/rechallenge) can also be included. Attention should be paid to not overburden the data collection system with details that are not used systematically for patient care and programme management. There may be a temptation to do this when electronic data systems are installed, but it should be avoided as it is a waste of resources and demotivating for the staff.
In places where the capacity to undertake routine M&E for the minimum indicators is still being built, the ministries of health and national programmes may consider a periodic analysis of medical records that can be done using a simple sampling methodology. Likewise, investigations on medication adherence and drug safety may be done as part of such a survey. Box 8.2 outlines an example on how to conduct annual patient record reviews which can be run rapidly by the programme staff with minimum financial and training resources focusing on household contacts. In many settings, service data for People with HIV on ART are captured within electronic data systems enabling varied analyses using unique personal identification (UID) across different data systems (such as cohort analysis of People with HIV newly enrolled in HIV care who were screened for TB, evaluated for TPT eligibility, started on TPT and completed TPT). Availability of UID enables de-duplication of entries and increases the reliability of data for programme management.
Monitoring TPT completion
It is important to monitor TPT completion both for individual care and programme management. The electronic data capture tool should record details of treatment outcomes for each individual starting TPT. TPT may be considered completed when an individual takes 80% or more of the prescribed number of doses of treatment within 133% of the scheduled duration of the respective TPT regimen and remains well or asymptomatic during the entire period (see also Table 5.3 on minimum number of doses to determine completion for different regimens. Other outcomes for TPT adherence are proposed in Chapter 5 to help in decisions for care of a person on TPT).
Data recording tools
National TB and HIV programmes use patient cards, medical histories, case files or electronic medical records as sources for information on TPT services. One of the key challenges in the scale-up of TPT services is the need to capture a diverse set of data, often relying on paper-based records and the involvement of multiple health care service providers. Programmes that monitor PMTPT usually capture data on paper tools, such as lists of contacts investigated in a household, or additional columns on an ARV register to record TPT initiated among People with HIV. These tools are reviewed periodically to derive indicators, usually requiring manual computation. Printing and updating of paper records adds to the burden on health care workers.
Data from TB programmes are increasingly being recorded electronically for people with TB disease who need treatment including ART. These databases are used to generate M&E indicators as well as to follow up patient treatment response. For PMTPT activities, in contrast, many programmes are yet to develop systematic electronic data collection mechanisms to generate programmatic indicators. WHO promotes the development of existing or new electronic systems to capture data elements that are needed for PMTPT care and monitoring to generate indicators automatically. Hand-held devices such as smartphones are particularly suitable because they can capture data from different sites critical to PMTPT activities, be it in the index patient’s home, an ARV clinic, hospital or an occupational/ immigration health centre (see Box 8.3).
With an increasing number of people being evaluated for TPT, more diverse options for TPT regimens (of differing compositions and durations), and a desire to disaggregate by various subpopulations at risk, it is more important to invest in electronic recording systems to enable accurate quantification, procurement and supplies of consumables. This information is also useful for planning of human and financial resources. As global access to affordable hardware, software and connectivity increases, realtime monitoring of the performance of PMTPT components becomes more feasible. Dedicated M&E staff should be assigned and trained to coordinate and build capacity at national and subnational levels in the use of data for decision-making. Countries should allocate a dedicated budget to digitize data capture and reporting and request funding from donors if there is a shortfall in funding.
Data confidentiality
Providing optimal TPT and care involves disclosure of personal information to the health care system. This sensitive information must be treated with the utmost confidentiality, in accordance with the professional code of conduct. It should be shared only with persons who need to know, usually those providing direct care. All documents containing confidential information must be securely stored. Duplicate and unnecessary paper-based work should be discouraged and destroyed when it is no longer needed. Computerized databases that contain sensitive information should be protected by coded passwords and encryption, with users granted access rights depending on their role. It is desirable to assign UIDs to individuals being evaluated for or administered TPT. The UID can help in matching and de-duplication of individual entries. Entries may be immediately de-identified after data aggregation. Personal details should be removed as soon as possible in data collection or reporting if they are no longer required for reporting purposes. Care should be taken when referrals are made to other services and when information on an individual is transferred from one care facility to another (either manually or electronically). Each programme should develop a policy to ensure confidentiality of personal data and if a national policy exists it should be enforced in all parts of the health sector. Information on how these data are handled should be part of the counselling provided to people who are offered TPT. Just as they are empowered to opt out of TPT, their decision about the use of their personal information should also be respected.
Supportive supervision
Good supportive supervision is an essential element for routine M&E of health facilities from central or district levels. It includes quality checks for data recording and reporting, including inspection and validation of a person’s case files and data collection tools for validity and completeness of recording. National programmes may provide a standard checklist to assess data quality and implementation across the cascade of care starting from identification of the target population for TPT initiation and completion. The frequency of supportive supervision depends on resources and needs, but closer monitoring may be needed for data quality assurance given that PMTPT is a relative novelty in many countries. Supervisory visits may also gather data for HMIS reporting. At least once a year, a data quality audit of routine monitoring systems may be carried out by the supervision team. This should involve members of both TB and HIV programmes and possibly others (such as prison health services and occupational health).
¹² World Bank Open Data. World Bank (https://data.worldbank.org/, accessed 21 March 2020).