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  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">JMU</journal-id>
      <journal-id journal-id-type="nlm-ta">JMIR Mhealth Uhealth</journal-id>
      <journal-title>JMIR mHealth and uHealth</journal-title>
      <issn pub-type="epub">2291-5222</issn>
      <publisher>
        <publisher-name>JMIR Publications</publisher-name>
        <publisher-loc>Toronto, Canada</publisher-loc>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id">v9i8e29381</article-id>
      <article-id pub-id-type="pmid">34420917</article-id>
      <article-id pub-id-type="doi">10.2196/29381</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Review</subject>
        </subj-group>
        <subj-group subj-group-type="article-type">
          <subject>Review</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Domains and Methods Used to Assess Home Telemonitoring Scalability: Systematic Review</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="editor">
          <name>
            <surname>Buis</surname>
            <given-names>Lorraine</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Trieste</surname>
            <given-names>Leopoldo</given-names>
          </name>
        </contrib>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Pit</surname>
            <given-names>Sabrina</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib id="contrib1" contrib-type="author" corresp="yes" equal-contrib="yes">
          <name name-style="western">
            <surname>Azevedo</surname>
            <given-names>Salome</given-names>
          </name>
          <degrees>MSc</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <address>
            <institution>Value for Health CoLAB</institution>
            <institution>NOVA Medical School</institution>
            <addr-line>Rua do Instituto Bacteriológico, no 5, 5-A e 5-B</addr-line>
            <addr-line>Lisbon, 1099-085</addr-line>
            <country>Portugal</country>
            <phone>351 218803110</phone>
            <email>salome.azevedo@vohcolab.org</email>
          </address>
          <xref rid="aff2" ref-type="aff">2</xref>
          <xref rid="aff3" ref-type="aff">3</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0003-1234-9464</ext-link>
        </contrib>
        <contrib id="contrib2" contrib-type="author" equal-contrib="yes">
          <name name-style="western">
            <surname>Rodrigues</surname>
            <given-names>Teresa Cipriano</given-names>
          </name>
          <degrees>MSc, PhD</degrees>
          <xref rid="aff3" ref-type="aff">3</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-7548-3794</ext-link>
        </contrib>
        <contrib id="contrib3" contrib-type="author" equal-contrib="yes">
          <name name-style="western">
            <surname>Londral</surname>
            <given-names>Ana Rita</given-names>
          </name>
          <degrees>MSc, PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <xref rid="aff2" ref-type="aff">2</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-8002-6790</ext-link>
        </contrib>
      </contrib-group>
      <aff id="aff1">
        <label>1</label>
        <institution>Value for Health CoLAB</institution>
        <institution>NOVA Medical School</institution>
        <addr-line>Lisbon</addr-line>
        <country>Portugal</country>
      </aff>
      <aff id="aff2">
        <label>2</label>
        <institution>Comprehensive Health Research Centre</institution>
        <institution>NOVA Medical School, UNL</institution>
        <addr-line>Lisbon</addr-line>
        <country>Portugal</country>
      </aff>
      <aff id="aff3">
        <label>3</label>
        <institution>CEG-IST, Centre for Management Studies of Instituto Superior Técnico</institution>
        <institution>Universidade de Lisboa</institution>
        <addr-line>Lisbon</addr-line>
        <country>Portugal</country>
      </aff>
      <author-notes>
        <corresp>Corresponding Author: Salome Azevedo <email>salome.azevedo@vohcolab.org</email></corresp>
      </author-notes>
      <pub-date pub-type="collection">
        <month>8</month>
        <year>2021</year>
      </pub-date>
      <pub-date pub-type="epub">
        <day>19</day>
        <month>8</month>
        <year>2021</year>
      </pub-date>
      <volume>9</volume>
      <issue>8</issue>
      <elocation-id>e29381</elocation-id>
      <history>
        <date date-type="received">
          <day>5</day>
          <month>4</month>
          <year>2021</year>
        </date>
        <date date-type="rev-request">
          <day>11</day>
          <month>6</month>
          <year>2021</year>
        </date>
        <date date-type="rev-recd">
          <day>25</day>
          <month>6</month>
          <year>2021</year>
        </date>
        <date date-type="accepted">
          <day>14</day>
          <month>7</month>
          <year>2021</year>
        </date>
      </history>
      <copyright-statement>©Salome Azevedo, Teresa Cipriano Rodrigues, Ana Rita Londral. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 19.08.2021.</copyright-statement>
      <copyright-year>2021</copyright-year>
      <license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/">
        <p>This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on https://mhealth.jmir.org/, as well as this copyright and license information must be included.</p>
      </license>
      <self-uri xlink:href="https://mhealth.jmir.org/2021/8/e29381" xlink:type="simple"/>
      <abstract>
        <sec sec-type="background">
          <title>Background</title>
          <p>The COVID-19 pandemic catalyzed the adoption of home telemonitoring to cope with social distancing challenges. Recent research on home telemonitoring demonstrated benefits concerning the capacity, patient empowerment, and treatment commitment of health care systems. Moreover, for some diseases, it revealed significant improvement in clinical outcomes. Nevertheless, when policy makers and practitioners decide whether to scale-up a technology-based health intervention from a research study to mainstream care delivery, it is essential to assess other relevant domains, such as its feasibility to be expanded under real-world conditions. Therefore, scalability assessment is critical, and it encompasses multiple domains to ensure population-wide access to the benefits of the growing technological potential for home telemonitoring services in health care.</p>
        </sec>
        <sec sec-type="objective">
          <title>Objective</title>
          <p>This systematic review aims to identify the domains and methods used in peer-reviewed research studies that assess the scalability of home telemonitoring–based interventions under real-world conditions.</p>
        </sec>
        <sec sec-type="methods">
          <title>Methods</title>
          <p>The authors followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines and used multiple databases (PubMed, Scopus, Web of Science, and EconLit). An integrative synthesis of the eligible studies was conducted to better explore each intervention and summarize relevant information concerning the target audience, intervention duration and setting, and type of technology. Each study design was classified based on the strength of its evidence. Lastly, the authors conducted narrative and thematic analyses to identify the domains, and qualitative and quantitative methods used to support scalability assessment.</p>
        </sec>
        <sec sec-type="results">
          <title>Results</title>
          <p>This review evaluated 13 articles focusing on the potential of scaling up a home telemonitoring intervention. Most of the studies considered the following domains relevant for scalability assessment: problem (13), intervention (12), effectiveness (13), and costs and benefits (10). Although cost-effectiveness was the most common evaluation method, the authors identified seven additional cost analysis methods to evaluate the costs. Other domains were less considered, such as the sociopolitical context (2), workforce (4), and technological infrastructure (3). Researchers used different methodological approaches to assess the effectiveness, costs and benefits, fidelity, and acceptability.</p>
        </sec>
        <sec sec-type="conclusions">
          <title>Conclusions</title>
          <p>This systematic review suggests that when assessing scalability, researchers select the domains specifically related to the intervention while ignoring others related to the contextual, technological, and environmental factors, which are also relevant. Additionally, studies report using different methods to evaluate the same domain, which makes comparison difficult. Future work should address research on the minimum required domains to assess the scalability of remote telemonitoring services and suggest methods that allow comparison among studies to provide better support to decision makers during large-scale implementation.</p>
        </sec>
      </abstract>
      <kwd-group>
        <kwd>telemonitoring</kwd>
        <kwd>scalability</kwd>
        <kwd>home telecare</kwd>
        <kwd>systematic review</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec sec-type="introduction">
      <title>Introduction</title>
      <p>The Universal Health Coverage commitment aligned with the emergence of COVID-19 reinforced the value of telemedicine services and elected these services crucial to coping with the pandemic’s challenges in the health care sector. Since the pandemic reached the western countries, home telemonitoring offered an alternative to control the health status of infected nonsevere patients at their homes to avoid unnecessary visits to the hospital [<xref ref-type="bibr" rid="ref1">1</xref>].</p>
      <p>During the early part of 2020, from a social perspective, the fast-track solution to prevent the spread of COVID-19 focused on social distancing [<xref ref-type="bibr" rid="ref2">2</xref>]. Governments forced people to stay at home, canceled mass gatherings, imposed teleworking, and closed all educational institutions [<xref ref-type="bibr" rid="ref3">3</xref>]. From a health care perspective, governments took some extreme measures to increase the capacity to cope with the virus, namely reduction or deferral of nonurgent care and hands-on visits, and postponement of nonurgent surgeries [<xref ref-type="bibr" rid="ref4">4</xref>]. These measures exposed high-risk groups, such as the elderly at home, people at long-term care facilities, patients with chronic conditions, and hidden diseases [<xref ref-type="bibr" rid="ref5">5</xref>]. Inevitably, physicians started following-up with their patients through video calls and remote monitoring to continue treatment and avoid long-term complications [<xref ref-type="bibr" rid="ref6">6</xref>]. In parallel, health care providers launched new telehealth services to assist patients in their homes [<xref ref-type="bibr" rid="ref7">7</xref>]. Policy makers and practitioners did not have enough information to decide which pilot intervention they should disseminate into real-world settings, considering different financial reimbursement strategies, health care system organizations, and workforce acceptance levels [<xref ref-type="bibr" rid="ref8">8</xref>].</p>
      <p>With technological progression and decreasing equipment costs, remote patient monitoring emerged as a telemedicine application. It comprises interactive and noninteractive technologies to support health care and monitor patients’ health status in their homes [<xref ref-type="bibr" rid="ref9">9</xref>].</p>
      <p>Home telemonitoring is one type of remote patient monitoring, which has shown and is showing potential to improve clinical and patient-reported outcomes and ensure cost reductions for health care practices [<xref ref-type="bibr" rid="ref10">10</xref>]. In this work, the authors consider the definition given by Paré and colleagues [<xref ref-type="bibr" rid="ref11">11</xref>] for home telemonitoring. A service based on home telemonitoring consists of health care professionals monitoring the patient's health status at a distance. Patients or caregivers transmit their health-related data to a responsible health care professional through information and telecommunication technologies. Research on home telemonitoring showed benefits concerning health care systems’ capacity constraints [<xref ref-type="bibr" rid="ref12">12</xref>], patient empowerment, and treatment commitment [<xref ref-type="bibr" rid="ref13">13</xref>]. It revealed significant improvement in clinical outcomes even in some diseases [<xref ref-type="bibr" rid="ref11">11</xref>]. Despite the considerable investment in accelerating health information technology [<xref ref-type="bibr" rid="ref14">14</xref>], there is not enough information on determining whether home telemonitoring is appropriate and feasible for implementation in a real-world context [<xref ref-type="bibr" rid="ref15">15</xref>]. Scaling up a health intervention requires wise and efficient spending of resources [<xref ref-type="bibr" rid="ref16">16</xref>]. Therefore, it is crucial to assess the suitability of scaling up home telemonitoring interventions with proven efficacy to provide answers to the following two questions [<xref ref-type="bibr" rid="ref17">17</xref>]: <italic>Does it work in practice? Is it worth it?</italic></p>
      <p>To answer these questions and decide which technology-based health intervention can be scaled up for mainstream care delivery, one must assess its scalability (ie, the ability to be expanded to real-world conditions without compromising on effectiveness and access to the eligible population) [<xref ref-type="bibr" rid="ref18">18</xref>].</p>
      <p>Most of the studies focus only on assessing the effectiveness and costs of a health intervention. Nevertheless, these are two of many considerations to address when evaluating the potential of scaling up an intervention [<xref ref-type="bibr" rid="ref19">19</xref>]. Other domains such as the feasibility and adaptability of the health intervention and the political or strategic contexts are rarely analyzed. As emphasized by Milat and his colleagues [<xref ref-type="bibr" rid="ref15">15</xref>] in their recently proposed Intervention Scalability Assessment Tool (ISAT), assessing a health intervention’s scalability involves considering multiple domains, such as the political and strategic contexts, workforce, and infrastructure, among others.</p>
      <p>There is a need to conduct evidence-based studies that assess pilot interventions’ potential to achieve population-wide benefits [<xref ref-type="bibr" rid="ref20">20</xref>]. Scalability studies that also consider the intervention’s suitability to the socioeconomic context in question are important to estimate the success of deploying these interventions in different contexts [<xref ref-type="bibr" rid="ref15">15</xref>].</p>
      <p>Owing to the lack of research on scalability analysis, in this paper, the authors present a systematic review, based on Milat and colleagues’ domains [<xref ref-type="bibr" rid="ref15">15</xref>], to identify and characterize methods used to assess the potential to scale-up home telemonitoring interventions in the context of a growing telehealth service in the industry. This study focuses on peer-reviewed studies conducted to evaluate the scalability of follow-up interventions based on home telemonitoring. The authors aim to provide a comprehensive overview of these studies concerning the domains and methods used and identify gaps for future research to address when evaluating the potential to implement or scale-up home telemonitoring interventions. As the authors are not aware of other systematic reviews focusing on this aspect, they believe that this review will enlighten researchers, practitioners, and policy makers regarding the most used strategies to assess the scalability of home telemonitoring interventions.</p>
    </sec>
    <sec sec-type="methods">
      <title>Methods</title>
      <p>The search strategy followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines to conduct the review [<xref ref-type="bibr" rid="ref21">21</xref>]. The population, intervention, comparison, outcome (PICO) framework [<xref ref-type="bibr" rid="ref21">21</xref>] allowed the identification of key concepts such as “Home Telemonitoring,” “Follow-up,” “Scalability,” and “Assessment” to formulate a well-focused question and facilitate the literature search. To optimize the search through effective queries, the authors used PubMed’s Medical Subject Headings (MeSH) to identify indexed terms [<xref ref-type="bibr" rid="ref22">22</xref>]. This step was fundamental as this review emerges from the combination of research fields with different terms for the same concept. <xref ref-type="boxed-text" rid="box1">Textbox 1</xref> presents the rationale used to build the final query used in each database.</p>
      <boxed-text id="box1" position="float">
        <title>Queries used to search each database.</title>
        <p>1. (((Telemonitoring) OR (Home remote monitoring)) AND (Mobile Health OR health OR mHealth OR eHealth OR Telehealth OR Telemedicine)) OR (Telehomecare)</p>
        <p>2. (Scalability) OR (Feasibility) OR (Scaling up OR scale up OR upscale OR up-scale OR scale-up) OR ((Deployment OR Implementation OR Application) OR (Broad-scale OR Wide-scale OR Widespread OR Mainstream)) OR (((Efficienc*) AND (Program OR Intervention)) OR Economic* Viability)</p>
        <p>3. (Follow-up Care* OR Follow Up Care* OR Care*) OR (Case Management OR Patient Care Planning)</p>
        <p>4. ((Appraisal* OR Evaluation* OR Assessment* OR Appropriateness) AND ((Impact) OR (Cost-Effective* OR Qualitative OR Quantitative OR Index* OR Methodolog*) OR (Clinical Trial* AND (Pragmatic OR Naturalistic Randomized OR Practical OR Real World)) OR (Sustainability) OR (Profitability) OR (Risk*)))</p>
        <p>5. #1 AND #2 AND #3 AND #4</p>
      </boxed-text>
      <p><xref rid="figure1" ref-type="fig">Figure 1</xref> illustrates the search performed in PubMed, Scopus, Web of Science, and EconLit covering studies from 2000 to 2020 (<xref rid="figure1" ref-type="fig">Figure 1</xref> - Set #1). The authors chose to explore EconLit owing to the economic evaluation required to assess a health care intervention’s scalability. The authors selected full-text and peer-reviewed papers written in English (<xref rid="figure1" ref-type="fig">Figure 1</xref> - Set #2).</p>
      <p>After removing the duplicates and references without abstracts (<xref rid="figure1" ref-type="fig">Figure 1</xref> - Set #3), two authors independently scanned the titles and abstracts identified in the literature search and applied the selection criteria presented in <xref ref-type="boxed-text" rid="box2">Textbox 2</xref> (<xref rid="figure1" ref-type="fig">Figure 1</xref> - Set #4).</p>
      <p>To guarantee that the article’s topic aligned with the research question, the same authors scanned the 49 full-text articles, which reduced the number of studies considered for review to 13 (Set #5).</p>
      <p>The authors analyzed 13 full-text articles, corresponding to 13 studies, in detail and registered all the observations in a literature matrix [<xref ref-type="bibr" rid="ref23">23</xref>]. First, to better explore each intervention and summarize relevant, well-specified, and secure data, the authors conducted an integrative synthesis. The main variables were the country of origin, publication year, sample size, setting, duration of follow-up, comparator arms, type of technology, and study outcomes [<xref ref-type="bibr" rid="ref24">24</xref>].</p>
      <p>Second, the authors assessed the strength of each eligible study’s evidence according to the 9-level classification system proposed by Jovell and Navarro-Rubio [<xref ref-type="bibr" rid="ref25">25</xref>].</p>
      <fig id="figure1" position="float">
        <label>Figure 1</label>
        <caption>
          <p>PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram showing the included studies.</p>
        </caption>
        <graphic xlink:href="mhealth_v9i8e29381_fig1.png" alt-version="no" mimetype="image" position="float" xlink:type="simple"/>
      </fig>
      <boxed-text id="box2" position="float">
        <title>Eligibility criteria for screening titles, abstracts, and full-text papers.</title>
        <p>
          <bold>Inclusion criteria</bold>
        </p>
        <list list-type="bullet">
          <list-item>
            <p>Health interventions shown to be efficacious on a small scale or under controlled conditions</p>
          </list-item>
          <list-item>
            <p>Assessment of the health intervention’s ability to be expanded to real-world conditions to reach a more significant proportion of the eligible population while retaining effectiveness.</p>
          </list-item>
          <list-item>
            <p>Studies assessing at least one domain of scalability through the evaluation of feasibility, acceptability, costs, sustainability or, adaptability (ie, to suit the needs of the context in which it is to be scaled up)</p>
          </list-item>
          <list-item>
            <p>Described methods to assess the scalability of a health intervention</p>
          </list-item>
        </list>
        <p>
          <bold>Exclusion criteria</bold>
        </p>
        <list list-type="bullet">
          <list-item>
            <p>Telemonitoring involving invasive medical devices</p>
          </list-item>
          <list-item>
            <p>Studies that use telemonitoring “not involving the patients, their relatives, or informal caregivers, their relatives, or informal caregivers</p>
          </list-item>
          <list-item>
            <p>Studies that described the concept of scalability without providing an assessment method</p>
          </list-item>
          <list-item>
            <p>Studies just focusing on describing disease risk patterns or intervention efficacy testing</p>
          </list-item>
          <list-item>
            <p>Study protocols or medical testing procedures for potential scalability assessment and possible scale-up</p>
          </list-item>
          <list-item>
            <p>Statistical or conceptual modeling without a real-world study</p>
          </list-item>
          <list-item>
            <p>Facilitators and barriers to scale-up within specific interventions or general experiences of scale-up that did not provide a scalability assessment method</p>
          </list-item>
          <list-item>
            <p>Studies recommending an assessment method (of feasibility or acceptability or costs or sustainability or adaptability), but that did not assess the potential to scale-up a telemonitoring-based health intervention</p>
          </list-item>
        </list>
      </boxed-text>
      <p>Finally, they conducted narrative and thematic analyses to identify themes and patterns in the eligible articles and outline the findings under specific headings [<xref ref-type="bibr" rid="ref24">24</xref>] to better examine how each study assessed the potential of scaling up an intervention. When disagreements occurred, the authors reached a consensus via discussion. One author extracted data from the studies and completed quotes, and the second author validated the data according to the definition of each category. The authors conducted this analysis based on the work undertaken by Milat and colleagues [<xref ref-type="bibr" rid="ref18">18</xref>] in the development of a tool to perform systematic assessments of the suitability of health interventions for scale-up (ISAT). ISAT comprises three parts: setting the scene, planning the intervention implementation, and summarizing the scalability assessment. The first two parts made it possible to classify each study according to the stage of scale-up, context, and focus area. Moreover, Milat and colleagues’ domains enabled the authors to identify the methods and instruments used by the researchers to assess the intervention’s scalability [<xref ref-type="bibr" rid="ref18">18</xref>].</p>
      <p>The research conducted for each domain assessed in the eligible papers was classified as qualitative or quantitative. The research was classified as qualitative if it was based on the description of experiences, emotions, behaviors, events, or actions [<xref ref-type="bibr" rid="ref26">26</xref>] and quantitative when the respective authors used numerical data to measure, categorize, or identify patterns, relationships, or generalizations through statistical analysis [<xref ref-type="bibr" rid="ref26">26</xref>].</p>
    </sec>
    <sec sec-type="results">
      <title>Results</title>
      <sec>
        <title>Country of Origin and Year of Publication</title>
        <p>From 2009 to 2020, the authors analyzed 13 studies in 7 countries, which focused on the potential to scale-up home telemonitoring health care interventions; however, more than half (n=7) were published between 2018 and 2020. Most of the articles (n=8) were from Canada and the United States, whereas the rest were from 5 European countries—Denmark (n=1), Italy (n=1), Lithuania (n=1), Netherlands (n=1), and Spain (n=1).</p>
      </sec>
      <sec>
        <title>Population and Home Telemonitoring Intervention Assessment</title>
        <sec>
          <title>Target Condition or Disease</title>
          <p>The studies addressed either chronic or acute conditions, with a higher number of studies addressing only chronic conditions (n=8). The full spectrum of chronic conditions covered were cardiovascular diseases (n=4), chronic obstructive pulmonary diseases (n=2), cerebrovascular diseases (n=1), chronic obstructive sleep apnea (n=1), cystic fibrosis (n=1), and diabetes mellitus (gestational [n=1] and type 1 and 2 [n=1]). Further, one study only characterized the patients’ condition as chronic or acute, and the remaining studies addressed multiple conditions (eg, surgical patients, cardiovascular and pulmonary diseases, diabetes mellitus).</p>
        </sec>
        <sec>
          <title>Duration and Setting of Home Telemonitoring Intervention</title>
          <p>Home telemonitoring was integrated into a follow-up service in the 13 studies and required a responsible health care professional (or a team) to manage the patient’s care. The minimum duration of the follow-up was 3 consecutive nights (sleep apnea [<xref ref-type="bibr" rid="ref27">27</xref>]). However, the 1-year (n=4) and 6-month (n=4) follow-up interventions were the most implemented. In particular, authors reporting the secondary prevention of cerebrovascular disease [<xref ref-type="bibr" rid="ref28">28</xref>] defined the intervention according to recommended monitoring protocols, assuming a 20-year time horizon for the modeling strategy. Moreover, 10 studies had 2 dedicated teams for executing the intervention; one was responsible for the patient’s holistic care management and the other for telecare management. In two studies, the conventional care team was accountable for usual care and telecare management, and in the other, there was no traditional care team.</p>
        </sec>
        <sec>
          <title>Types of Technologies</title>
          <p>The technologies used in the studies ranged from a kit with just one regular telephone (1) to an integrated communication and data collection system with mobile devices (5). Moreover, six studies conducted home telemonitoring interventions with an integrated clinical data system, remote monitoring digital technology (mobile devices that collect physiological signs), and a telephone.</p>
        </sec>
      </sec>
      <sec>
        <title>Study Design Assessment</title>
        <sec>
          <title>Study Characteristics</title>
          <p>The average total sample size of the studies was approximately 436 (maximum: 3086, minimum: 34), with an average treatment and control group size of 260.</p>
          <p>To better understand the type of research conducted, it is essential to highlight that 6 out of the 13 studies were experimental. Therefore, the authors of these studies allocated participants to different treatment groups. As the other 7 studies were observational, there was no allocation of the participants. Most of the studies (n=10) were comparative studies (control group) with conventional care services, and the other 3 were single-arm studies.</p>
        </sec>
        <sec>
          <title>Study Design Classification</title>
          <p>According to the 9-level classification system proposed by Jovell and Navarro-Rubio [<xref ref-type="bibr" rid="ref25">25</xref>], the studies conducted by Padwal and colleagues [<xref ref-type="bibr" rid="ref28">28</xref>], and Vestergaard and colleagues [<xref ref-type="bibr" rid="ref29">29</xref>] were classified as “very good,” as they conducted randomized controlled trials with large samples. The studies by Lugo and colleagues [<xref ref-type="bibr" rid="ref27">27</xref>], and Paré and colleagues [<xref ref-type="bibr" rid="ref30">30</xref>] were classified as “good” as these studies were randomized controlled trials with small samples. Furthermore, the studies of Ware and colleagues [<xref ref-type="bibr" rid="ref31">31</xref>], as well as Zaliūnas and colleagues [<xref ref-type="bibr" rid="ref32">32</xref>], were classified as “poor” because they consisted of noncontrolled clinical series or descriptive studies. The other 7 were classified as fair and included nonrandomized controlled prospective studies (n=3), cohort studies (n=3), and case-control studies (n=1).</p>
        </sec>
      </sec>
      <sec>
        <title>Scalability Assessment</title>
        <p><xref ref-type="table" rid="table1">Table 1</xref> displays the scalability assessment domains for each study.</p>
        <table-wrap position="float" id="table1">
          <label>Table 1</label>
          <caption>
            <p>Scalability assessment domains for each study.</p>
          </caption>
          <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
            <col width="120"/>
            <col width="80"/>
            <col width="70"/>
            <col width="80"/>
            <col width="50"/>
            <col width="80"/>
            <col width="100"/>
            <col width="0"/>
            <col width="80"/>
            <col width="80"/>
            <col width="80"/>
            <col width="90"/>
            <col width="90"/>
            <thead>
              <tr valign="top">
                <td>Application field</td>
                <td>Stage of scale-up</td>
                <td colspan="6">Domains for scale-up</td>
                <td colspan="5">Domains for implementation planning</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>
                  <break/>
                </td>
                <td>Problem</td>
                <td>Intervention</td>
                <td>Context</td>
                <td>Effectiveness</td>
                <td>Costs and benefits</td>
                <td colspan="2">Fidelity and adaptability</td>
                <td>Reach and acceptability</td>
                <td>Setting and workforce</td>
                <td>Infrastructure</td>
                <td>Sustainability</td>
              </tr>
            </thead>
            <tbody>
              <tr valign="top">
                <td>Improved health outcomes in a rural area [<xref ref-type="bibr" rid="ref33">33</xref>]</td>
                <td>Pre–scale-up</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">No</td>
                <td>Yes</td>
                <td>No</td>
                <td>No</td>
                <td>No</td>
              </tr>
              <tr valign="top">
                <td>Diabetes [<xref ref-type="bibr" rid="ref34">34</xref>]</td>
                <td>Pre–scale-up</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
              </tr>
              <tr valign="top">
                <td>Cystic fibrosis [<xref ref-type="bibr" rid="ref35">35</xref>]</td>
                <td>Pre–scale-up</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>No</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">No</td>
                <td>No</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
              </tr>
              <tr valign="top">
                <td>Chronic heart failure [<xref ref-type="bibr" rid="ref36">36</xref>]</td>
                <td>Pre–scale-up</td>
                <td>Yes</td>
                <td>No</td>
                <td>No</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">No</td>
                <td>No</td>
                <td>No</td>
                <td>No</td>
                <td>No</td>
              </tr>
              <tr valign="top">
                <td>Obstructive sleep apnea [<xref ref-type="bibr" rid="ref27">27</xref>]</td>
                <td>Pre–scale-up</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>No</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
              </tr>
              <tr valign="top">
                <td>Secondary prevention of cerebrovascular disease [<xref ref-type="bibr" rid="ref28">28</xref>]</td>
                <td>Pre–scale-up</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">Yes</td>
                <td>No</td>
                <td>No</td>
                <td>No</td>
                <td>Yes</td>
              </tr>
              <tr valign="top">
                <td>Heart failure [<xref ref-type="bibr" rid="ref29">29</xref>]</td>
                <td>Pre–scale-up</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">No</td>
                <td>No</td>
                <td>No</td>
                <td>No</td>
                <td>No</td>
              </tr>
              <tr valign="top">
                <td>Gestational diabetes mellitus [<xref ref-type="bibr" rid="ref37">37</xref>]</td>
                <td>Pre–scale-up</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
              </tr>
              <tr valign="top">
                <td>Rural home health agencies [<xref ref-type="bibr" rid="ref38">38</xref>]</td>
                <td>Scale-up</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">Yes</td>
                <td>Yes</td>
                <td>No</td>
                <td>Yes</td>
                <td>Yes</td>
              </tr>
              <tr valign="top">
                <td>Chronic obstructive pulmonary disease [<xref ref-type="bibr" rid="ref30">30</xref>]</td>
                <td>Scale-up</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td colspan="2">No</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
              </tr>
              <tr valign="top">
                <td>Ischemic heart disease [<xref ref-type="bibr" rid="ref32">32</xref>]</td>
                <td>Implementation</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>No</td>
                <td colspan="2">Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
              </tr>
              <tr valign="top">
                <td>Heart failure [<xref ref-type="bibr" rid="ref31">31</xref>]</td>
                <td>Implementation</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>No</td>
                <td colspan="2">Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
              </tr>
              <tr valign="top">
                <td>Chronic obstructive pulmonary disease [<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                <td>Implementation</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>No</td>
                <td colspan="2">No</td>
                <td>Yes</td>
                <td>Yes</td>
                <td>Yes</td>
                <td> Yes</td>
              </tr>
            </tbody>
          </table>
        </table-wrap>
        <sec>
          <title>Scale-Up Stages</title>
          <p>The authors classified eight studies as being in the pre–scale-up stage because their descriptions consisted of steps or activities conducted before scaling up the evidence-based home telemonitoring intervention. Two studies described steps or actions involved in the dissemination of the intervention. The authors classified the other three studies as being in the implementation stage because their descriptions indicated using or integrating the evidence-based intervention within a setting.</p>
        </sec>
        <sec>
          <title>Domains Considered for Scale-Up</title>
          <p>Although all the studies described the problem under intervention and the target population, one study [<xref ref-type="bibr" rid="ref36">36</xref>] did not provide details concerning the proposed home telemonitoring intervention to address the issue. All studies referred to the level of evidence available to support the proposed intervention’s scale-up, either by referring to their work or other scientific literature., Three studies did not consider the known costs and benefits of delivering the intervention [<xref ref-type="bibr" rid="ref31">31</xref>,<xref ref-type="bibr" rid="ref32">32</xref>,<xref ref-type="bibr" rid="ref39">39</xref>], and three more did not consider the strategic/political/environmental contexts that influence the scaling up of the intervention [<xref ref-type="bibr" rid="ref27">27</xref>,<xref ref-type="bibr" rid="ref35">35</xref>,<xref ref-type="bibr" rid="ref36">36</xref>].</p>
        </sec>
        <sec>
          <title>Domains Considered for Implementation Planning</title>
          <p>Seven studies considered intervention changes when assessing fidelity, and nine studies assessed the level of acceptability perceived by the program deliverers or recipients of the intervention. Further, 9 studies referred to the definition of the intervention settings and the workforce required to scale-up, and 10 described the necessary infrastructure.</p>
          <p>All the studies accounted for the sustainability of the home telemonitoring service by either referring to the long-term outcomes of the scale-up or the medium- and long-term sustainability of the intervention following scale-up.</p>
        </sec>
        <sec>
          <title>Methods for Scalability Assessment</title>
          <p>This section explains the research foci and methods used by the eligible studies in each domain of scalability assessment. When describing the problems, interventions, and contexts of their studies, all the researchers adopted qualitative research methods, as <xref ref-type="table" rid="table2">Table 2</xref> shows. The definitions of the domains and research foci are given in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref>. We have included six publications [<xref ref-type="bibr" rid="ref40">40</xref>-<xref ref-type="bibr" rid="ref45">45</xref>] in this appendix.</p>
          <table-wrap position="float" id="table2">
            <label>Table 2</label>
            <caption>
              <p>Qualitative studies on scalability assessment considering the problem, intervention, and context domains for scale-up.</p>
            </caption>
            <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
              <col width="100"/>
              <col width="150"/>
              <col width="160"/>
              <col width="190"/>
              <col width="190"/>
              <col width="100"/>
              <col width="110"/>
              <thead>
                <tr valign="top">
                  <td>Domain</td>
                  <td>Research focus</td>
                  <td>Research type</td>
                  <td>Data collection technique</td>
                  <td>Data analysis technique</td>
                  <td>Studies, n</td>
                  <td>Reference</td>
                </tr>
              </thead>
              <tbody>
                <tr valign="top">
                  <td>Problem</td>
                  <td>Problem description</td>
                  <td>Qualitative</td>
                  <td>Document analysis</td>
                  <td>Narrative summary</td>
                  <td>13</td>
                  <td>[<xref ref-type="bibr" rid="ref27">27</xref>-<xref ref-type="bibr" rid="ref39">39</xref>,<xref ref-type="bibr" rid="ref46">46</xref>-<xref ref-type="bibr" rid="ref50">50</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Intervention</td>
                  <td>Intervention description</td>
                  <td>Qualitative</td>
                  <td>Document analysis</td>
                  <td>Narrative summary</td>
                  <td>12</td>
                  <td>[<xref ref-type="bibr" rid="ref27">27</xref>-<xref ref-type="bibr" rid="ref35">35</xref>,<xref ref-type="bibr" rid="ref37">37</xref>-<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Context</td>
                  <td>Context description</td>
                  <td>Qualitative</td>
                  <td>Document analysis</td>
                  <td>Narrative summary</td>
                  <td>10</td>
                  <td>[<xref ref-type="bibr" rid="ref28">28</xref>-<xref ref-type="bibr" rid="ref34">34</xref>,<xref ref-type="bibr" rid="ref37">37</xref>-<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
              </tbody>
            </table>
          </table-wrap>
          <p>All the studies adopted quantitative research methods to assess clinical outcomes namely surveys or questionnaires (n=10), published databases (n=2), and observations (n=1) (<xref ref-type="table" rid="table3">Table 3</xref>). To assess humanistic and satisfaction outcomes, the researchers chose surveys or questionnaires; however, for assessing for usage outcomes, they either conducted observations (n=9) or used published databases (n=3). As for validated instruments, only one was used in one study [<xref ref-type="bibr" rid="ref27">27</xref>] to assess clinical outcomes, namely the Epworth Sleepiness Scale (ESS) [<xref ref-type="bibr" rid="ref51">51</xref>]. For assessing humanistic outcomes, three validated questionnaires were used: EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) [<xref ref-type="bibr" rid="ref52">52</xref>] in the contexts of heart failure [<xref ref-type="bibr" rid="ref29">29</xref>] and obstructive sleep apnea [<xref ref-type="bibr" rid="ref27">27</xref>]; Quebec Sleep Questionnaire (QSQ) [<xref ref-type="bibr" rid="ref53">53</xref>] for obstructive sleep apnea; and Chronic obstructive pulmonary disease Assessment Test (CAT) [<xref ref-type="bibr" rid="ref54">54</xref>] for chronic obstructive pulmonary disease [<xref ref-type="bibr" rid="ref39">39</xref>]. In the context of ischemic heart disease [<xref ref-type="bibr" rid="ref32">32</xref>], two more validated questionnaires were used: Patient Satisfaction Questionnaire Form III (PSQIII) [<xref ref-type="bibr" rid="ref55">55</xref>] and Thought Control Questionnaire (TCQ) [<xref ref-type="bibr" rid="ref56">56</xref>].</p>
          <table-wrap position="float" id="table3">
            <label>Table 3</label>
            <caption>
              <p>Quantitative research studies involving data analyses using descriptive and inferential statistics for scalability assessment considering the effectiveness domain for scale-up.</p>
            </caption>
            <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
              <col width="30"/>
              <col width="570"/>
              <col width="250"/>
              <col width="150"/>
              <thead>
                <tr valign="top">
                  <td colspan="2">Research focus and data collection technique<break/>  <break/>  </td>
                  <td>Studies, n</td>
                  <td>Reference</td>
                </tr>
              </thead>
              <tbody>
                <tr valign="top">
                  <td colspan="4">
                    <bold>Clinical outcome assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Observation; published databases</td>
                  <td>3</td>
                  <td>[<xref ref-type="bibr" rid="ref28">28</xref>,<xref ref-type="bibr" rid="ref36">36</xref>,<xref ref-type="bibr" rid="ref38">38</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Nonvalidated surveys or questionnaires</td>
                  <td>9</td>
                  <td>[<xref ref-type="bibr" rid="ref29">29</xref>-<xref ref-type="bibr" rid="ref35">35</xref>,<xref ref-type="bibr" rid="ref37">37</xref>,<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Validated surveys or questionnaires</td>
                  <td>1</td>
                  <td>[<xref ref-type="bibr" rid="ref27">27</xref>]</td>
                </tr>
                <tr valign="top">
                  <td colspan="4">
                    <bold>Humanistic outcome assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Nonvalidated surveys or questionnaires</td>
                  <td>3</td>
                  <td>[<xref ref-type="bibr" rid="ref32">32</xref>-<xref ref-type="bibr" rid="ref34">34</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Validated surveys or questionnaires</td>
                  <td>3</td>
                  <td>[<xref ref-type="bibr" rid="ref27">27</xref>,<xref ref-type="bibr" rid="ref29">29</xref>,<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
                <tr valign="top">
                  <td colspan="4">
                    <bold>Satisfaction assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Nonvalidated surveys or questionnaires</td>
                  <td>7</td>
                  <td>[<xref ref-type="bibr" rid="ref27">27</xref>,<xref ref-type="bibr" rid="ref29">29</xref>,<xref ref-type="bibr" rid="ref30">30</xref>,<xref ref-type="bibr" rid="ref33">33</xref>,<xref ref-type="bibr" rid="ref34">34</xref>,<xref ref-type="bibr" rid="ref37">37</xref>,<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Validated surveys or questionnaires</td>
                  <td>1</td>
                  <td>[<xref ref-type="bibr" rid="ref32">32</xref>]</td>
                </tr>
              </tbody>
            </table>
          </table-wrap>
          <p>For the domains of fidelity and acceptability, quantitative research methods involving observations were more predominantly used as the main data collection methods, as shown in <xref ref-type="table" rid="table4">Tables 4</xref> and <xref ref-type="table" rid="table5">5</xref>. Contrarily, for analyzing infrastructure, setting, and workforce, most of the studies chose qualitative techniques (n=8).</p>
          <table-wrap position="float" id="table4">
            <label>Table 4</label>
            <caption>
              <p>Studies on scalability assessment concerning the reach and acceptability domain for implementation planning involving data analyses using descriptive and inferential statistics.</p>
            </caption>
            <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
              <col width="30"/>
              <col width="370"/>
              <col width="250"/>
              <col width="0"/>
              <col width="180"/>
              <col width="0"/>
              <col width="170"/>
              <thead>
                <tr valign="top">
                  <td colspan="2">Research focus and type</td>
                  <td colspan="2">Data collection technique</td>
                  <td colspan="2">Studies, n</td>
                  <td>Reference</td>
                </tr>
              </thead>
              <tbody>
                <tr valign="top">
                  <td colspan="7">
                    <bold>Acceptability assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Quantitative</td>
                  <td>Observation</td>
                  <td colspan="2">7</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref27">27</xref>,<xref ref-type="bibr" rid="ref30">30</xref>,<xref ref-type="bibr" rid="ref32">32</xref>-<xref ref-type="bibr" rid="ref34">34</xref>,<xref ref-type="bibr" rid="ref37">37</xref>,<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Qualitative</td>
                  <td>Semistructured interviews</td>
                  <td colspan="2">1</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref38">38</xref>]</td>
                </tr>
                <tr valign="top">
                  <td colspan="7">
                    <bold>Compliance assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Quantitative</td>
                  <td>Nonvalidated surveys or questionnaires</td>
                  <td colspan="2">1</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref31">31</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Quantitative</td>
                  <td>Validated surveys or questionnaires</td>
                  <td colspan="2">1</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref32">32</xref>]</td>
                </tr>
                <tr valign="top">
                  <td colspan="7">
                    <bold>Penetration assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Quantitative</td>
                  <td>Observation</td>
                  <td colspan="2">2</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref31">31</xref>,<xref ref-type="bibr" rid="ref37">37</xref>]</td>
                </tr>
              </tbody>
            </table>
          </table-wrap>
          <table-wrap position="float" id="table5">
            <label>Table 5</label>
            <caption>
              <p>Research focus and methods found in the studies for scalability assessment concerning the fidelity and adaptability domain for implementation planning.</p>
            </caption>
            <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
              <col width="30"/>
              <col width="230"/>
              <col width="0"/>
              <col width="200"/>
              <col width="0"/>
              <col width="200"/>
              <col width="0"/>
              <col width="170"/>
              <col width="0"/>
              <col width="170"/>
              <thead>
                <tr valign="top">
                  <td colspan="3">Research focus and type<break/>  <break/>  </td>
                  <td colspan="2">Data collection technique</td>
                  <td colspan="2">Data analysis technique</td>
                  <td colspan="2">Studies, n</td>
                  <td>Reference</td>
                </tr>
              </thead>
              <tbody>
                <tr valign="top">
                  <td colspan="10">
                    <bold>Adaptability assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Quantitative</td>
                  <td colspan="2">Observation</td>
                  <td colspan="2">Descriptive statistics; inferential statistics</td>
                  <td colspan="2">1</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref27">27</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Qualitative</td>
                  <td colspan="2">Observations; oral history or life stories</td>
                  <td colspan="2">Narrative summary</td>
                  <td colspan="2">2</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref32">32</xref>,<xref ref-type="bibr" rid="ref38">38</xref>]</td>
                </tr>
                <tr valign="top">
                  <td colspan="10">
                    <bold>Feasibility assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Quantitative</td>
                  <td colspan="2">Observation</td>
                  <td colspan="2">Descriptive statistics; inferential statistics</td>
                  <td colspan="2">2</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref31">31</xref>,<xref ref-type="bibr" rid="ref37">37</xref>]</td>
                </tr>
              </tbody>
            </table>
          </table-wrap>
          <p>When conducting economic evaluation (<xref ref-type="table" rid="table6">Table 6</xref>), the authors found 7 different types of techniques used across 10 studies (see <xref ref-type="supplementary-material" rid="app2">Multimedia Appendix 2</xref> for the main results of the studies that conducted economic evaluation of home telemonitoring). The most popular technique was cost-effectiveness analysis used in three studies with different fields of application. These three studies were able to show outcome improvements and cost savings. <xref ref-type="table" rid="table7">Table 7</xref> presents the scalability assessment studies concerning the setting and workforce, infrastructure, and sustainability domains for implementation planning</p>
          <table-wrap position="float" id="table6">
            <label>Table 6</label>
            <caption>
              <p>Quantitative research studies focusing on data collection using document screening and published databases for scalability assessment considering the costs and benefits domain for scale-up (research focus: economic evaluation).</p>
            </caption>
            <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
              <col width="350"/>
              <col width="350"/>
              <col width="300"/>
              <thead>
                <tr valign="top">
                  <td>Data analysis technique</td>
                  <td>Studies, n</td>
                  <td>Reference</td>
                </tr>
              </thead>
              <tbody>
                <tr valign="top">
                  <td>Cost analysis</td>
                  <td>2</td>
                  <td>[<xref ref-type="bibr" rid="ref34">34</xref>,<xref ref-type="bibr" rid="ref35">35</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Cost-benefit</td>
                  <td>1</td>
                  <td>[<xref ref-type="bibr" rid="ref38">38</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Cost-effectiveness</td>
                  <td>3</td>
                  <td>[<xref ref-type="bibr" rid="ref27">27</xref>,<xref ref-type="bibr" rid="ref33">33</xref>,<xref ref-type="bibr" rid="ref37">37</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Cost minimization</td>
                  <td>1</td>
                  <td>[<xref ref-type="bibr" rid="ref30">30</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Cost utility</td>
                  <td>2</td>
                  <td>[<xref ref-type="bibr" rid="ref28">28</xref>,<xref ref-type="bibr" rid="ref29">29</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Cost-saving simulation</td>
                  <td>1</td>
                  <td>[<xref ref-type="bibr" rid="ref35">35</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Value of information analysis</td>
                  <td>1</td>
                  <td>[<xref ref-type="bibr" rid="ref36">36</xref>]</td>
                </tr>
              </tbody>
            </table>
          </table-wrap>
          <table-wrap position="float" id="table7">
            <label>Table 7</label>
            <caption>
              <p>Studies on scalability assessment concerning the setting and workforce, infrastructure, and sustainability domains for implementation planning.</p>
            </caption>
            <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
              <col width="30"/>
              <col width="30"/>
              <col width="270"/>
              <col width="0"/>
              <col width="230"/>
              <col width="0"/>
              <col width="160"/>
              <col width="0"/>
              <col width="100"/>
              <col width="0"/>
              <col width="180"/>
              <thead>
                <tr valign="top">
                  <td colspan="4">Domain and research focus and type</td>
                  <td colspan="2">Data collection technique</td>
                  <td colspan="2">Data analysis technique</td>
                  <td colspan="2">Studies, n</td>
                  <td>Reference</td>
                </tr>
              </thead>
              <tbody>
                <tr valign="top">
                  <td colspan="11">
                    <bold>Setting and workforce</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td colspan="10">
                    <bold>Setting and workforce assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>
                    <break/>
                  </td>
                  <td>Qualitative</td>
                  <td colspan="2">Observations; oral history or life stories</td>
                  <td colspan="2">Narrative summary</td>
                  <td colspan="2">8</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref27">27</xref>,<xref ref-type="bibr" rid="ref28">28</xref>,<xref ref-type="bibr" rid="ref31">31</xref>,<xref ref-type="bibr" rid="ref32">32</xref>,<xref ref-type="bibr" rid="ref34">34</xref>,<xref ref-type="bibr" rid="ref35">35</xref>,<xref ref-type="bibr" rid="ref37">37</xref>,<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>
                    <break/>
                  </td>
                  <td>Quantitative</td>
                  <td colspan="2">Observation</td>
                  <td colspan="2">Descriptive statistics</td>
                  <td colspan="2">1</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref30">30</xref>]</td>
                </tr>
                <tr valign="top">
                  <td colspan="11">
                    <bold>Infrastructure</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td colspan="10">
                    <bold>Infrastructure assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>
                    <break/>
                  </td>
                  <td>Qualitative</td>
                  <td colspan="2">Observations; oral history or life stories</td>
                  <td colspan="2">Narrative summary</td>
                  <td colspan="2">9</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref27">27</xref>,<xref ref-type="bibr" rid="ref28">28</xref>,<xref ref-type="bibr" rid="ref30">30</xref>,<xref ref-type="bibr" rid="ref32">32</xref>,<xref ref-type="bibr" rid="ref34">34</xref>,<xref ref-type="bibr" rid="ref35">35</xref>,<xref ref-type="bibr" rid="ref37">37</xref>-<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>
                    <break/>
                  </td>
                  <td>Qualitative</td>
                  <td colspan="2">Semistructured Interviews</td>
                  <td colspan="2">Descriptive statistics</td>
                  <td colspan="2">1</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref31">31</xref>]</td>
                </tr>
                <tr valign="top">
                  <td colspan="11">
                    <bold>Sustainability</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td colspan="10">
                    <bold>Opportunity and challenge assessment</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>
                    <break/>
                  </td>
                  <td>Qualitative</td>
                  <td colspan="2">Observations; oral history or life stories</td>
                  <td colspan="2">Narrative summary</td>
                  <td colspan="2">12</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref27">27</xref>-<xref ref-type="bibr" rid="ref30">30</xref>,<xref ref-type="bibr" rid="ref32">32</xref>-<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>
                    <break/>
                  </td>
                  <td>Qualitative</td>
                  <td colspan="2">Semistructured interviews</td>
                  <td colspan="2">Narrative summary</td>
                  <td colspan="2">1</td>
                  <td colspan="2">[<xref ref-type="bibr" rid="ref31">31</xref>]</td>
                </tr>
              </tbody>
            </table>
          </table-wrap>
        </sec>
        <sec>
          <title>Scalability Assessment</title>
          <p>All the 13 articles assessed scalability based on the results achieved in the respective studies. <xref ref-type="table" rid="table8">Table 8</xref> summarizes the assessments obtained through narrative analysis. On the one hand, two studies provided positive assessments regarding the potential to scale-up the intervention. On the other hand, eight studies highlighted the need for cost-effectiveness or cost-benefit analysis before proceeding to scale-up the intervention.</p>
          <table-wrap position="float" id="table8">
            <label>Table 8</label>
            <caption>
              <p>Scalability assessment based on the authors’ conclusions in each study.</p>
            </caption>
            <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
              <col width="650"/>
              <col width="100"/>
              <col width="250"/>
              <thead>
                <tr valign="top">
                  <td>Scalability assessment</td>
                  <td>Studies, N</td>
                  <td>Reference</td>
                </tr>
              </thead>
              <tbody>
                <tr valign="top">
                  <td><italic>Not</italic> able to be expanded</td>
                  <td>1</td>
                  <td>[<xref ref-type="bibr" rid="ref27">27</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Able to be expanded, <italic>but</italic> the diffusion and sustainability will depend on a supportive policy environment</td>
                  <td>1</td>
                  <td>[<xref ref-type="bibr" rid="ref34">34</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Able to be expanded <italic>but</italic> requires cost-benefit analysis for reimbursement planning</td>
                  <td>3</td>
                  <td>[<xref ref-type="bibr" rid="ref28">28</xref>,<xref ref-type="bibr" rid="ref36">36</xref>,<xref ref-type="bibr" rid="ref38">38</xref>,<xref ref-type="bibr" rid="ref39">39</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Able to be expanded <italic>but</italic> requires cost-effectiveness analysis</td>
                  <td>3</td>
                  <td>[<xref ref-type="bibr" rid="ref29">29</xref>,<xref ref-type="bibr" rid="ref30">30</xref>,<xref ref-type="bibr" rid="ref35">35</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Able to be expanded <italic>but</italic> requires some technical changes, cost-benefit analysis for reimbursement planning, and solutions for regulatory issues</td>
                  <td>2</td>
                  <td>[<xref ref-type="bibr" rid="ref32">32</xref>,<xref ref-type="bibr" rid="ref33">33</xref>]</td>
                </tr>
                <tr valign="top">
                  <td>Able to be expanded under real-world conditions</td>
                  <td>2</td>
                  <td>[<xref ref-type="bibr" rid="ref31">31</xref>,<xref ref-type="bibr" rid="ref37">37</xref>]</td>
                </tr>
              </tbody>
            </table>
          </table-wrap>
        </sec>
      </sec>
    </sec>
    <sec sec-type="discussion">
      <title>Discussion</title>
      <sec>
        <title>Principal Results</title>
        <p>Despite the rapid growth of telemedicine applications in the last few years, particularly after the emergence of COVID-19, scientific studies assessing the scalability of these health interventions are scarce [<xref ref-type="bibr" rid="ref19">19</xref>].</p>
        <p>In this review, all the eligible studies are from developed countries, particularly the United States and Canada. The absence of such studies in developing countries could be owing to the lack of specialized human resources, information and communications technology (ICT) infrastructure, and equipment [<xref ref-type="bibr" rid="ref46">46</xref>]. Besides, the significant difference found between North America and Europe might be related to the requirement of evidence to justify private payer reimbursement for health care interventions [<xref ref-type="bibr" rid="ref47">47</xref>] or the investment in developing strategies to encourage telemedicine adoption [<xref ref-type="bibr" rid="ref48">48</xref>]. Nevertheless, this review has not identified studies from countries that invested significantly in telehealth solutions, such as the United Kingdom or Australia [<xref ref-type="bibr" rid="ref46">46</xref>]. The justification for this might be the frequent research focus of health interventions on clinical effectiveness [<xref ref-type="bibr" rid="ref11">11</xref>], instead of assessing their scale-up potential. More than half of the studies were published between 2018 and 2020. Thus, this research area is receiving more attention from the scientific community as a logical next step after demonstrating robust evidence regarding the effectiveness and technological maturity of such interventions.</p>
        <p>The use of one of the most recent scalability assessment frameworks [<xref ref-type="bibr" rid="ref18">18</xref>] granted the opportunity to compare the strategies used to assess the scale-up potentials of interventions in each study. This advantage of this framework is that it allows the analysis of different domains considering the stage of the transference process of an intervention from a research setting into the practical implementation stage.</p>
        <p>This review suggests an agreement in some analyzed domains, such as problems, interventions, effectiveness, costs, and benefits, to support the decision to scale-up interventions. However, this is not the case for the methods and instruments used. For example, although cost-effectiveness was the most common approach across the 13 studies, researchers used 7 different cost analysis methods. Moreover, to demonstrate effectiveness, studies provided evidence of different outcomes, such as clinical, humanistic, and utilization outcomes. This inconsistency leads to different scalability assessments and does not enable comparing interventions with home telemonitoring technologies.</p>
        <p>There is a recognized methodological gap in understanding other relevant domains such as the sociopolitical context, setting, workforce, and implementation infrastructure to provide the home telemonitoring intervention to the target population. A common framework will allow determining if interventions demonstrated as effective are appropriate and feasible in other settings [<xref ref-type="bibr" rid="ref18">18</xref>,<xref ref-type="bibr" rid="ref49">49</xref>].</p>
        <p>Lastly, another relevant result obtained from this systematic review was that researchers assigned different weights to the analyzed domains when concluding the intervention scalability. On the one hand, 12 studies concluded their ability to scale- up based on the costs and outcomes of the interventions, although they had analyzed other domains. On the other hand, one study restrained the decision to scale-up the intervention based on the policy environment. Future research should address the influence that each domain has on the final decision to scale-up the interventions with sound and transparent methods, avoiding mistakes reported in the literature [<xref ref-type="bibr" rid="ref50">50</xref>].</p>
      </sec>
      <sec>
        <title>Limitations</title>
        <p>This relevant limitation of this review might be associated with the low maturity of this research area, despite its recent growth. Additionally, one database filter concerned peer-reviewed journals, which influenced the rejection of studies with no statistical significance but could have been relevant in this review with respect to the domains and methods used when assessing scalability. This review only considered studies published in English, which might have influenced the number of eligible studies. Moreover, the authors did not conduct a meta-analysis owing to the limited number of studies on this subject. Finally, the domains used to analyze the scalability assessment strategies were predefined, thus limiting the spectrum of domains studied.</p>
      </sec>
      <sec>
        <title>Conclusions</title>
        <p>Studies on home telemonitoring interventions integrated into follow-up care have already proved their efficacy. Although some studies focused on including domains such as effectiveness, costs, and benefits, these are not enough to assess the potential of scaling up these interventions. As technology progresses and the need for providing care to more people in their homes increases, it is extremely important to conduct more studies on scalability assessment considering domains such as workforce and infrastructure characteristics and the strategic context. Future research should establish rigorous study designs and scientific methods to assess scalability based on the results of this systematic review. Further understanding of the usage of health services and medium- and long-term sustainability of interventions would yield more robust evidence to support their future integration into mainstream care delivery systems. This research area, although still emerging, will advance knowledge on the factors that influence the successful scale-up of interventions.</p>
      </sec>
    </sec>
  </body>
  <back>
    <app-group>
      <supplementary-material id="app1">
        <label>Multimedia Appendix 1</label>
        <p>Glossary of research methods and scalability assessment domains used to systematically review the eligible studies in this work.</p>
        <media xlink:href="mhealth_v9i8e29381_app1.pdf" xlink:title="PDF File  (Adobe PDF File), 82 KB"/>
      </supplementary-material>
      <supplementary-material id="app2">
        <label>Multimedia Appendix 2</label>
        <p>Main results of the economic evaluations conducted in each eligible study that addressed the domains of costs and benefits.</p>
        <media xlink:href="mhealth_v9i8e29381_app2.pdf" xlink:title="PDF File  (Adobe PDF File), 77 KB"/>
      </supplementary-material>
    </app-group>
    <glossary>
      <title>Abbreviations</title>
      <def-list>
        <def-item>
          <term id="abb1">CAT</term>
          <def>
            <p>Chronic Obstructive Pulmonary Disease Assessment Test</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb2">EQ-5D-5L</term>
          <def>
            <p>EuroQol 5-Dimensions 5-Levels</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb3">ESS</term>
          <def>
            <p>Epworth Sleepiness Scale</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb4">ICT</term>
          <def>
            <p>information and communications technology</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb5">ISAT</term>
          <def>
            <p>Intervention Scalability Assessment Tool</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb6">MeSH</term>
          <def>
            <p>Medical Subject Heading</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb7">PRISMA</term>
          <def>
            <p>Preferred Reporting Items for Systematic Reviews and Meta-Analysis</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb8">PSQIII</term>
          <def>
            <p>Patient Satisfaction Questionnaire Form III</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb9">QSQ</term>
          <def>
            <p>Quebec Sleep Questionnaire</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb10">TCQ</term>
          <def>
            <p>Thought Control Questionnaire</p>
          </def>
        </def-item>
      </def-list>
    </glossary>
    <ack>
      <p>We are thankful to Professor Mónica Oliveira for her support and guidance in the ideation process of this systematic review. In addition, we are grateful for the funding provided by Portugal 2020, under the scope of PROJETOS DE I&#38;DT EMPRESAS EM COPROMOÇÃO - COVID-19 (15/SI/2020) and the project Fast Track Covid, LISBOA-01-02B7-FEDER-069202.</p>
    </ack>
    <fn-group>
      <fn fn-type="conflict">
        <p>None declared.</p>
      </fn>
    </fn-group>
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