Understanding implementation research
Digital technologies have emerged as novel approaches to improving patient outcomes and pragmatic use of resources by tuberculosis (TB) programmes. The increasing global availability of such technologies, resulting from decreasing hardware prices and expanding cellular and internet coverage, has enabled their wider use for improved health outcomes, including at critical stages of the TB patient pathway.
However, the strength of evidence supporting the application of new digital technologies is limited. While some digital tools applied to TB or related health care practice areas (e.g. antiretroviral treatment) have demonstrated an impact on improving health outcomes or resource management under experimental research conditions (e.g. randomized controlled trials and quasi-experimental studies), others rely instead on observational or descriptive evidence, such as surveillance of process indicators or case studies of best practice. Even when high-quality evidence exists, these results often cannot be reproduced under real-world and programmatic conditions. This is due in large part to the local and contextual factors that shape the usability and effectiveness of digital technologies in such real-world settings and which play an important role in how the technology is rolled out, used and accessed, maintained, scaled up and integrated into policies and practices.
Implementation Research (IR) is the systematic approach to understanding and addressing how these local factors and contexts shape the effective and quality delivery of health interventions1,2 in order to maximize their overall impact (Fig. 1). The third pillar of the WHO End TB strategy3 is Intensified Research and Innovation. Under this pillar, there are two closely interlinked components: A) Discovery, development and rapid uptake of new tools, interventions and strategies, and; B) Research to optimize implementation and impact and to promote innovations. IR bridges the gap between tools, interventions or strategies proven efficacious under research conditions, and their effective implementation in real-life situations by identifying the factors that prevent or reduce potential impact during scale up and integration into routine programmatic settings. For example, compliance and uptake of a digital technology could be affected by factors including the level of technological ownership or literacy in a community, the willingness among providers and patients to adopt a new technology, or the behaviour changes needed for effective use. Knowledge from this type of IR can broaden our understanding of how and when digital interventions can be adopted to improve the impact of TB programmes and promote wider integration into national operational plans.
Users of this toolkit are assumed to have some pre-existing knowledge of IR, possibly following completion of the related TDR massive open online course (MOOC).4 Users wanting to learn more about the theory and background of IR are also encouraged to review the original Implementation Research Toolkit.
The Implementation research for digital technologies and tuberculosis toolkit (IR4DTB) guides users to conceptualize, design and implement IR studies aimed at optimizing the use of digital interventions within TB programmes. The three main IR4DTB objectives are to:
- encourage the use of IR as a method to evaluate the implementation of digital technologies for TB;
- build capacity within the TB workforce to design and conduct IR studies; and
- support IR fundraising efforts by supporting the development of a comprehensive study proposal.
Intended users are national TB programme implementers (middle- and senior-level managers), intergovernmental partners (such as the Stop TB Partnership and specialized UN agencies), technical partners (such as academic and research institutions, digital health technology companies), and nongovernmental organizations (NGOs) who have an interest in, or experience with, implementing digital technologies for TB, and who wish to conduct IR to optimize these technologies. Users should have a good understanding of the functioning of TB programmes and some knowledge about digital technologies and research techniques.
Other decision-makers (for example, such as ministry of health staff, national health policy-makers, budget-makers) and funders (for example, multilateral donors, global development and/or philanthropic organizations) may also benefit from the IR guidance provided in this toolkit.
Users of this toolkit likely identify with the following scenarios:
- You or your colleagues have identified a digital intervention as having potential to address a specific barrier or challenge in a TB programme, but you are not sure how best to adapt and/or implement it.
- You or your colleagues are currently using a digital technology and are interested in evaluating its success, scaling it up, or maximizing its impact.
- You or your colleagues have identified a challenge or bottleneck that is compromising the implementation impact and are interested in identifying, trialling, and evaluating new strategies to help address the issue.
How to use this toolkit
The toolkit contains six modules that reflect key steps in the IR process, taking a stepwise approach to introduce the notions of IR and how to make choices at different stages. The toolkit is intended to be worked through sequentially, but the modules may also function as stand-alone resources according to individual users' needs. The six modules have been specifically designed to facilitate the development of a comprehensive IR proposal that can be used to support future fundraising efforts (Table 1).
Before using this toolkit, we recommended users complete the Massive Online Open Course (MOOC) on IR offered by the Special Programme for Research and Training in Tropical Diseases (TDR) of the World Health Organization (WHO).4 The MOOC introduces the fundamental terms, concepts and principles of IR and their application, and explains the basic components of IR frameworks and key constraints to implementation. This free course is available online and is delivered in English with subtitles in English, French and Spanish. The course contains five modules to be completed over six weeks, requiring around 20 hours for completion.
Users of this IR4DTB toolkit should have at least a basic understanding of IR. However, the toolkit includes references and recommended readings for users who would like to learn more about key topics, and so the toolkit can also be used effectively by those who have not yet completed the MOOC.
Throughout this toolkit, real-life case studies of digital technologies applied to TB programmes illustrate how technologies and IR concepts have been applied across diverse settings and challenges. Where necessary, examples of digital technologies employed in other areas of health care (e.g. HIV programmes) are also used. These examples have been adapted from case studies provided by country teams and/or from associated published journal articles, and are included throughout the toolkit to illustrate various IR proposal components.
The case studies have been selected to represent the four digital functions outlined in the Digital health for the end of TB strategy: an agenda for action.9 The toolkit offers a conceptual framework using four broad categories in which a digital technology can be used to support TB prevention and care:
Digital technology for patient care aims to promote treatment success by facilitating contact between TB patients and their treatment provider or clinician, providing reminders or notifications about treatment and/or follow up appointments. Patient care also covers digital tools to deliver and monitor access to social support initiatives focusing on treatment adherence. Examples of technologies under this digital function include digital treatment reminders or medication monitors; video or virtual directly observed treatment support (known as VOT); SMS-based communication for treatment and follow up to cash transfers mediated via mobile devices.
Surveillance and monitoring
Digital surveillance and monitoring technologies have been used for several decades to facilitate the management and reporting of TB data by health personnel and programme managers. Apart from improving data access, quality and validity, digitization also enables linking across various electronic repositories – known as interoperability – that contain relevant records such as laboratory, pharmacy and mortality. Electronic TB surveillance registers typically include utilities such as dashboards to summarize TB indicators and trends in real-time.
Digitally connected systems can improve access to health and logistics information for providers and patients. Examples include information systems for drug stocks that can help planners know in real time the availability of consumables when providing a service to lessen waste or stock-outs. A common example in TB programmes are laboratory information systems that aim to improve the accuracy and turnaround time of test results. The increasing availability of diagnostic systems that generating digital outputs has brought the prospect of 'diagnostic connectivity' into reach for more settings, such as those which are remote or peripheral.
eLearning technologies aim to expand access and dissemination of educational information. Course materials may be administered entirely via digital platforms or as part of a 'blended learning' model, which integrates electronic media and devices with traditional classroom instruction. eLearning technologies may also leverage innovative methods of instruction, including gamification (a 'games' approach to learning), virtual or augmented reality to deliver information, and collaborative learning environments such as online discussions and information sharing. Examples of eLearning include web-based trainings on TB care for health providers, web-based clinical decision support systems for clinicians, and online support programmes for patients.