For the scoping review, Arksey and O’Malley’s framework, [26] which has been further revised by Levac et al [27] and Joanna Briggs Institute (JBI) [28] will be used. Five stages or categories based on these methodologies of scoping review are identified as follows: (a) identify research question; (b) identification of relevant studies; (c) study selection (d) charting the data by synthesizing and interpreting the extracted information; (e) collate, summarize, and report the outcomes.
Stage 1: Identify the research questions
The research questions for this scoping review were drafted and finalized with a collaborative approach by the research team (RK and AV). In the first stage, an initial review of literature was conducted on LTBI and associated digital health interventions with the help of “Google Scholar”. This stage supported the decision to not limit the criteria based on specific study population (at risk individuals- children, adolescents, adults etc.) as referred in the WHO’s updated and consolidated guidelines for LTBI programmatic management[3]. The guidelines include the population which comprises of infants, children, adolescents, and adults living with or without HIV and also primary contact(s) of a patient with pulmonary TB at household [3]. Based on the literature review, the following research questions were finalized- (i) what digital health interventions are available to manage LTBI? (ii) Describe the various elements of digital health interventions and their mode of delivery (iii) what populations and in what settings the digital health interventions have been implemented and (iv) To report outcomes on the available evidence on the impact of digital health interventions for LTBI care.
Stage 2. Identifying relevant studies- Search terms (key words), inclusion, and exclusion criteria
According to the Arksey and O’Malley’s framework [26], this stage of scoping review process aims to identifying the relevant literature. The search will be conducted using Medical Subject Heading (MeSH) and identified keywords through the MeSH library [29]. Search items were developed based on the condition, intervention, and study design as no restriction were in place for population and context of the study to retrieve majority of articles (Table 1).
Table 1: Search terms
Search Items
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Search terms
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Condition
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Latent Tuberculosis, latent tuberculosis infection, latent TB, latent tuberculosis disease, LTBI, TB preventive therapy
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Intervention
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Digital health, digital adherence technology, eHealth, mobile health, mHealth, technology, telemedicine, mobile, real time, video, informatics, cell Phone, smartphone, Text Messaging, mobile care, Mobile applications, TXT, PXT, MMS, SMS, short messaging service, mobile communication, mobile telecommunication, mobile technology, cellular technology, pc tablet, computer tablet, pocket pc, PDA phone, blackberry, palm pilot, pilot palm, wearables, point of care devices, Interactive voice response, IVR, GPRS, Bluetooth, GPS, global positioning system
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Study design
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Experimental study, randomized control trial, matched comparison, quasi-experimental design, pre-post study, before vs after
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Searches will be carried out in PubMed, Scopus, Web of Science, Cochrane and Embase databases using Boolean operators without any specific timeframe. The reference list of all included articles found will be scanned for any eligible literature. Articles published in English language only will be included. Search strategy has been established to identify all probable articles globally (table 2).
Table 2: Search Strategy
Sl. No.
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Search Strategy
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#1
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Latent Tuberculosis OR latent tuberculosis infection OR latent TB OR latent tuberculosis disease OR LTBI OR TB preventive therapy
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#2
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(digital OR digital health OR digital adherence technology OR eHealth OR mHealth OR technology OR telemedicine OR mobile OR real time OR video OR informatics OR cell Phone OR smartphone OR Text Messaging OR mobile care OR Mobile applications OR TXT OR PXT OR MMS OR SMS OR short messaging service OR mobile communication OR mobile telecommunication OR mobile technology OR cellular technology OR computer tablet OR pocket pc OR PDA phone OR blackberry OR palm pilot OR pilot palm OR wearables OR point of care devices OR Interactive voice response OR IVR OR GPRS OR Bluetooth OR GPS OR global positioning system
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#3
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Experimental study OR Randomized control trial OR RCT OR controlled trial OR matched comparison OR quasi-experimental design OR before vs after OR pre post study
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#4
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#1 AND #2
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#5
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#3 AND #4
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Table 3: Eligibility criteria for the studies
Population
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No restriction for the inclusion of population. With or without at-risk population including infants, children, adolescents, and adults will be eligible.
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Intervention
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Digital health interventions delivered by any means- mHealth, eHealth, SMS etc based on LTBI will be included.
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Comparator
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Studies other than digital health intervention for LTBI or studies with no intervention in the comparison group will serve as a comparator
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Outcomes
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Type of digital technology used, domains of digital health technology, implementation approach for the digital health intervention (mobile apps, SMS, voice call etc], tuberculosis prevention, LTBI diagnosis, treatment completion and adherence
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Study design
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RCT, quasi experimental study designs, before vs after study design with or without comparison group will be included in this review
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Stage 3. Study selection
This stage of Arksey and O’Malley’s framework [26] includes the identification of eligible studies based on the eligibility criteria in this scoping review using Rayyan.qcri.org software [30]. Searches will run on given databases and subsequently duplicate articles will be removed. No date restrictions will be placed in while conduct the searched. Two independent authors (SB and RK) will be conducting title-abstract screening and full text screening. All reasons for excluded studies at full text screening phase will be documented. Any disagreement between the reviewers at screening stage for inclusion or exclusion of the study will be solved through discussion to reach a mutual consensus or by arbitrated by the third reviewer, if required. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) will be generated to demonstrate the study selection process [31].
Stage 4. Charting the data
In this stage of the Arksey and O’Malley’s framework [26], charting of the data from selected studies will be performed. Data will be extracted in Microsoft Excel 2019 by two authors independently using standardized, pre-tested data extraction form. Any disagreement in extracted data will be solved by discussion and through mutual consensus. AV and RK will develop the data extraction form in consultation with technical expertise from public health researchers and knowledge expert in the field of LTBI or digital health technology. This form will be piloted on 5 percent of the studies to ensure it collects the information what it is required based on review’s objective. Data extraction will be conducted under few major domains: (i) Study characteristics or bibliometric information (Study title, authors, journal/source, publication year, country, population characteristics- age, gender, literacy level- both participants and service providers); (ii) methodological characteristics (study design, sampling, sample size and intervention delivered by whom); (iii) Operational definitions if available (iv) Intervention (type, frequency, duration, method used, type of comparator etc); (v) Outcomes related to digital health intervention, diagnosis, treatment, adherence, and completion for LTBI. Included studies will also be assessed for their implementation approach based on WHO’s Monitoring and Evaluating Digital Health intervention stages maturity life cycle i.e pre-prototype, prototype, pilot, demonstration, scale up and integration /sustainability [15].
Critical Appraisal
The critical appraisal of the identified studies will be performed using the Joanna Briggs critical appraisal tools, based on the study design [32]. The quality of selected studies will be assessed independently by two authors (RK and AV) and any differences in opinion will be resolved through discussion to reach consensus. The appraisal outcome or overall risk assessment will be portrayed in tabular format and will be discussed using systematic narrative synthesis.
Stage 5. Collating, summarising, and reporting the results
In this stage of the Arksey and O’Malley’s framework [26], the analysis of the extracted data will provide information on the amount of research or digital health interventions for LTBI rather than quality of the individual studies. For example, evidence on digital health intervention to prevent LTBI will be presented by the type of intervention, country, components of intervention, population covered, method of delivering the intervention like SMS, Google Play or IOS application etc. This review will also report the domain of intervention which have been under evaluated or reported. Results will be reported using appropriate charts and tabular format.
Ethics and dissemination
The scoping review does not require data collection from primary source, or direct or indirect human subject interaction. It aims at synthesizing data from publicly available resources; therefore, no ethical approval is required to conduct this scoping review. For dissemination purpose, the scoping review will be published in a peer- reviewed journal and findings of this review would be presented at relevant international and national conferences.