E-registry
Matilda Equiluz
Processing of submissions is set by respective legal standards and standard of Information System of Public Administration which deals with operation of the e-registry in relation to using advanced electronic signature (issued by UVIS no. 016/01.01).
The e-registry of the Office for the Protection of Competition is eligible to receive submissions with senders electronic signature (it is possible to use it within any kind of electronic submission) based on the qualified certificate issued by accredited provider of certification services (e.g. I.CA). The submission signed electronically is of the same legal value as documents in paper form with handwritten signature.
In parallel with their paper records, seven dispensaries in Ulaanbaatar, Mongolia collected standardized data electronically using Open Data Kit (ODK). Patients with MDRTB and their contacts were recruited during a single clinic visit. Staff and patients were interviewed to gain insights into acceptability and to identify areas for improvement.
Paper registry satisfaction was low; 88% of staff preferred the e-registry as it was perceived as faster and more secure. Patients and their contacts were generally supportive of the e-registry; however, a significant minority 10/42 (24%) of index cases who were invited, declined to participate in the e-registry, with data security cited as their top concern.
Despite having been recommended by the World Health Organization (WHO) since 2006, and repeatedly thereafter [1,2,3,4,5,6], contact tracing for multidrug resistant tuberculosis (MDRTB), remains a low priority within national TB programs in many low and middle-income countries where TB burden is high. In 2017, only a quarter of the estimated 558,000 rifampicin resistant and multidrug resistant tuberculosis (RR/MDRTB) cases worldwide were enrolled on effective treatment, with many dying even before a diagnosis could be made [7]. Significant improvement in MDRTB case ascertainment is essential to meet the END-TB strategy targets on reducing TB incidence and mortality [6, 7]. Observational data in support of the need to provide treatment for latent TB infection (LTBI) presumed to be MDR is gradually accumulating [8, 9] and three randomised controlled trials of preventive therapy for MDR exposed contacts are now underway [10,11,12].
The WHO has developed a set of global recommendations for TB contact investigation and these encourage the use of a set of standardised approaches to programme monitoring and evaluation. Heterogeneity of data collection between centres and of clinical definitions in datasets collected by various agencies remain a barrier to effective global monitoring. Whilst the WHO guidelines include precise definitions of index cases, close contacts and household contacts [5, 16, 17], a minimum dataset for an MDRTB contact registry has yet to be internationally agreed [9, 18] and no agency currently provides support in the form of data collection tools through which such a dataset could be uniformly collected, aggregated, analysed and disseminated.
Open Data Kit (ODK, ) is a free open source data collection toolkit allowing developers to design forms for an android application (app) ODK collect. Working in Botswana, Ha and colleagues developed an electronic data collection (EDC) solution based on ODK and used this to facilitate screening of TB contacts during household visits [21]. They concluded that using ODK reduced the time taken to complete tracing for each contact and scored favourably for user satisfaction among the health workers who conducted the tracing [21].
Paper based methods remain the standard approach in those few countries which currently undertake any MDRTB contact tracing with or without subsequent surveillance. Very few studies have evaluated the feasibility and acceptability of EDC tools in these countries [22]. Where these have been addressed, data accuracy and completeness remain an issue and none of this work has been completed in MDRTB contact tracing [23, 24]. In this study we aimed to evaluate the feasibility of a novel mobile electronic data collection tool for the building of a web-based MDRTB contact e-registry, and we collected descriptive epidemiological data on contacts.
The study was carried out in Mongolia, where in 2017 the estimated incidence rate then was 428/100,000 with a TB disease notification rate of 136/100,000, and a case detection rate of 32% [25]. 12.6% of laboratory confirmed cases were MDR [26]. MDRTB contact tracing has been national policy since 2006, though implementation is patchy. In 2016, 5.7% of identified household contacts developed active TB [26]. Contact tracing is done through district dispensaries where patients receive directly observed treatment (DOT).
Seven dispensaries were selected to participate based on their case load and physical proximity. At the time of the study 283 patients were receiving treatment for MDR-TB across these sites, these accounted for 57% of the national MDR-TB cases [26]. They covered six districts, all within Ulaanbaatar city limits, facilitating access for the investigators to as many sites as possible within the limited time frame of the study.
Personal identifiable information was first collected on a registration form which was encrypted before transmission to the server, remaining encrypted until downloaded and decrypted with a 2048-bit RSA key. Once data collection forms were marked as complete, they were no longer accessible through the ODK collect application, but the data could be accessed by the National Centre of Communicable Diseases (NCCD) on the ODK aggregate server, decrypted locally and emailed back to clinics on a scheduled basis in PDF or XLS format with end to end encryption. Patient data was not then available to view on the tablet.
For this study each dispensary was issued with an android tablet preloaded with the data collection forms on ODK collect. Local procurement of tablets or the use of staffs personal devices would also be feasible as the ODK data collections forms are downloaded to each device from the aggregate server. All dispensaries were already equipped with wired internet access, but WiFi routers were installed to allow the tablets internet access on-site. Security locks and applock software were installed on the tablets to prevent unauthorised access as well as restricting the use of the tablets. All dispensary staff had prior computer literacy with experience in using a PC for electronic data capture, as well as personal access to smartphones. However, none had reported experience of electronic data capture with a tablet computer. All staff were trained to recruit and consent participants, operate the tablets and app, and provided with a written manual and contact details for technical support. Staff continued recording all contact tracing activities on the paper-based registries during the study. Data was extracted into Microsoft Excel 2016 to calculate interquartile range (IQR).
The definitions for the index case and household contact used 2012 WHO recommendations [5], the definition for close contact was based on the Mongolian tuberculosis program guidelines, which uses a higher threshold than the WHO [28].
Index case: The initially identified patient with new or recurrent TB in a specific household or comparable setting in which others may have been exposed. Note: The index case is the initial patient accessing healthcare, they may not be the source case.
In this study we have developed and evaluated the feasibility and acceptability of an electronic MDRTB contact registry. A high yield of 10% (7/70) secondary TB cases in contacts reaffirms the importance of contact tracing and of a standardised and systematic approach to contact tracing in this setting.
Most of the data collected for the MDRTB contact registry overlaps with data collection necessary for the MDRTB index registry; a more unified system would therefore reduce duplication. Furthermore, many MDRTB patients have previously been treated for drug susceptible TB and using a common registration system across all types of TB disease could help prevent information on discrete sub-populations from forming data silos. Linking records across these different registries to avoid the duplication would be simpler in an electronic system and offer another advantage over paper.
There is a desire to improve the current MDRTB contact tracing and an e-registry is recognised as a way to achieve this by most patients and staff. However, refusal to participate in the e-registry by 10/42 (24%) of the index MDRTB cases invited does raise a concern regarding the acceptability of an e-registry hindering the contact tracing practices. Although not identified in the questionnaires, it is possible non-participation of indexes may have been influenced by the nature of presenting the e-registry as a research project co-ordinated by an external organisation, as opposed to paper registry which had been presented as being a routine part of their clinical management. As a result, this may have heightened the concerns regarding data security.
It is not possible for staff to view or search the registry from the ODK collect app, meaning they needed a separate way to access patient registry numbers, essential in linking the correct patient record. In effect, a second paper registry was made for the ODK registry to work. This duplication is inefficient and a potential source for error.
There is a clear need for an e-registry that provides a secure user interface. Two promising alternative systems are TUBIS and DHIS2, both are web based and allow the registry to be searched, simplifying it for users to retrieve patient records and add further data to the correct record. Each of the electronic registry systems mentioned above have their own relative merits and limitations [19]. WHO are now collaborating to provide support for TB patient data reporting using the DHIS2 platform. Inclusion of TB contacts in this software would be a logical next step [29, 30].
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