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  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">ResProt</journal-id>
      <journal-id journal-id-type="nlm-ta">JMIR Res Protoc</journal-id>
      <journal-title>JMIR Research Protocols</journal-title>
      <issn pub-type="epub">1929-0748</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">v12i1e42339</article-id>
      <article-id pub-id-type="pmid">37129935</article-id>
      <article-id pub-id-type="doi">10.2196/42339</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Protocol</subject>
        </subj-group>
        <subj-group subj-group-type="article-type">
          <subject>Protocol</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>The Impact of Secure Messaging in the Treatment of Patients With Diabetes Within a Primary Care Setting: Protocol for a Scoping Review</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="editor">
          <name>
            <surname>Mavragani</surname>
            <given-names>Amaryllis</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Barker</surname>
            <given-names>Anna</given-names>
          </name>
        </contrib>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Arnoldussen</surname>
            <given-names>Barbara</given-names>
          </name>
        </contrib>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Kragen</surname>
            <given-names>Benjamin</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib id="contrib1" contrib-type="author" corresp="yes">
          <name name-style="western">
            <surname>Lawal</surname>
            <given-names>Abdul</given-names>
          </name>
          <degrees>MBA</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <address>
            <institution>School of Public Health</institution>
            <institution>University of Alberta</institution>
            <addr-line>3032, Research Transition Facility</addr-line>
            <addr-line>8308 114 Street</addr-line>
            <addr-line>Edmonton, AB, T6G 1C9</addr-line>
            <country>Canada</country>
            <phone>1 780 710 8403</phone>
            <email>alawal1@ualberta.ca</email>
          </address>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-6942-0973</ext-link>
        </contrib>
        <contrib id="contrib2" contrib-type="author">
          <name name-style="western">
            <surname>Menon</surname>
            <given-names>Devidas</given-names>
          </name>
          <degrees>PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-4172-8634</ext-link>
        </contrib>
        <contrib id="contrib3" contrib-type="author">
          <name name-style="western">
            <surname>Affleck</surname>
            <given-names>Ewan</given-names>
          </name>
          <degrees>CM, BSc, MDCM</degrees>
          <xref rid="aff2" ref-type="aff">2</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0001-8402-9254</ext-link>
        </contrib>
        <contrib id="contrib4" contrib-type="author">
          <name name-style="western">
            <surname>Stafinski</surname>
            <given-names>Tania</given-names>
          </name>
          <degrees>PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0001-6679-7823</ext-link>
        </contrib>
      </contrib-group>
      <aff id="aff1">
        <label>1</label>
        <institution>School of Public Health</institution>
        <institution>University of Alberta</institution>
        <addr-line>Edmonton, AB</addr-line>
        <country>Canada</country>
      </aff>
      <aff id="aff2">
        <label>2</label>
        <institution>College of Physicians &#38; Surgeons of Alberta</institution>
        <addr-line>Edmonton, AB</addr-line>
        <country>Canada</country>
      </aff>
      <author-notes>
        <corresp>Corresponding Author: Abdul Lawal <email>alawal1@ualberta.ca</email></corresp>
      </author-notes>
      <pub-date pub-type="collection">
        <year>2023</year>
      </pub-date>
      <pub-date pub-type="epub">
        <day>2</day>
        <month>5</month>
        <year>2023</year>
      </pub-date>
      <volume>12</volume>
      <elocation-id>e42339</elocation-id>
      <history>
        <date date-type="received">
          <day>1</day>
          <month>9</month>
          <year>2022</year>
        </date>
        <date date-type="rev-request">
          <day>29</day>
          <month>11</month>
          <year>2022</year>
        </date>
        <date date-type="rev-recd">
          <day>13</day>
          <month>3</month>
          <year>2023</year>
        </date>
        <date date-type="accepted">
          <day>4</day>
          <month>4</month>
          <year>2023</year>
        </date>
      </history>
      <copyright-statement>©Abdul Lawal, Devidas Menon, Ewan Affleck, Tania Stafinski. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 02.05.2023.</copyright-statement>
      <copyright-year>2023</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 Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.</p>
      </license>
      <self-uri xlink:href="https://www.researchprotocols.org/2023/1/e42339" xlink:type="simple"/>
      <abstract>
        <sec sec-type="background">
          <title>Background</title>
          <p>Diabetes—a high-burden chronic disease—requires lifetime active management involving the use of different tools and health care resources to improve patient health outcomes. Recent studies have demonstrated promising results regarding the impact of the use of virtual care technology on the treatment of chronic diseases, such as diabetes. However, it is unclear whether the use of technologies, such as secure messaging, improves the quality of care and reduces diabetes-related costs to the health care system.</p>
        </sec>
        <sec sec-type="objective">
          <title>Objective</title>
          <p>The purpose of our scoping review is to explore what is known about the use of secure messaging in the treatment of diabetes within the primary care setting and how its impact has been assessed from the patient and health system perspectives. Our review aims to understand to what extent secure messaging improves the quality of diabetes care.</p>
        </sec>
        <sec sec-type="methods">
          <title>Methods</title>
          <p>Our scoping review will follow the 6-step Arksey and O’Malley methodological framework, as well as the Joanna Briggs Institute methodology for scoping reviews and their recommended tools. The tools to guide the development and reporting of the review in a structured way will include the Population, Concept, and Context framework and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines and checklist. The search strategy was developed iteratively in collaboration with a professional information specialist. Furthermore, a peer review of electronic search strategies was also conducted by an independent, third-party, professional information specialist. A systematic literature search will be conducted against databases, including Ovid MEDLINE ALL, Embase, APA PsycINFO, Cochrane Library on Wiley, CINAHL on EBSCO, and PubMed. Grey literature sources will also be searched for relevant literature. Literature on the use of secure messaging in the treatment of diabetes (types 1 and 2) within a primary care setting will be included. Two reviewers will review the literature based on the inclusion criteria in the following two steps: (1) title and abstract review and (2) full-text review. Discrepancies will be discussed to reach consensus where possible; otherwise, a third reviewer will resolve the dispute.</p>
        </sec>
        <sec sec-type="results">
          <title>Results</title>
          <p>The results and a final report are expected to be completed and submitted to a peer-reviewed journal in 6 months.</p>
        </sec>
        <sec sec-type="conclusions">
          <title>Conclusions</title>
          <p>The review will examine existing literature to identify the impact of secure messaging in diabetes treatment within primary care settings. Research gaps will also be identified to determine if there is a need for further studies.</p>
        </sec>
        <sec sec-type="registered-report">
          <title>International Registered Report Identifier (IRRID)</title>
          <p>DERR1-10.2196/42339</p>
        </sec>
      </abstract>
      <kwd-group>
        <kwd>secure messaging</kwd>
        <kwd>secure message</kwd>
        <kwd>text messaging</kwd>
        <kwd>security</kwd>
        <kwd>privacy</kwd>
        <kwd>chronic disease</kwd>
        <kwd>chronic condition</kwd>
        <kwd>primary care</kwd>
        <kwd>health outcome</kwd>
        <kwd>diabetic</kwd>
        <kwd>diabetes</kwd>
        <kwd>virtual care</kwd>
        <kwd>scoping review</kwd>
        <kwd>review methodology</kwd>
        <kwd>health care system</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec sec-type="introduction">
      <title>Introduction</title>
      <p>The prevalence of diabetes worldwide is expected to continue to rise. From 2010 to 2030, the prevalence of diabetes among individuals aged 20 to 79 years will likely increase from 6.4% to 7.7% worldwide and from 11.6% to 13.9% in Canada [<xref ref-type="bibr" rid="ref1">1</xref>].</p>
      <p>Diabetes is an endocrine disorder that arises from the body’s inability to produce insulin, effectively use it, or both, resulting in an unhealthy rise in blood sugar levels. Insulin is a hormone that is produced by the pancreas to regulate blood sugar. Consequences of unmanaged diabetes include pain, nerve damage, amputation, the failure of different organs, cardiovascular diseases, and more. Complications of this disease are very serious and can lead to death [<xref ref-type="bibr" rid="ref2">2</xref>,<xref ref-type="bibr" rid="ref3">3</xref>].</p>
      <p>Canada’s public health care system spends billions of dollars annually in the treatment of chronic diseases, and this cost is rising due to population growth and improvements in screening, diagnosis, and care. Diabetes Canada estimated the direct cost of diabetes to the Canadian health care system to be about CAD $32 billion (approximately US $24 billion) in 2023 and predicted it to reach about CAD $39 billion (approximately US $29 billion) by 2028 [<xref ref-type="bibr" rid="ref3">3</xref>]. The province of Alberta spends approximately twice as much money on patients with diabetes compared to the amount of money it spends on those without it [<xref ref-type="bibr" rid="ref4">4</xref>].</p>
      <p>The recent COVID-19 pandemic has acted as a catalyst for the adoption of virtual care technology and services around the world, including Canada. The Canadian government continues to invest in virtual care technology (eg, secure messaging technology, videoconferencing technology, and other tools), in addition to the billions of dollars already invested in digital health [<xref ref-type="bibr" rid="ref5">5</xref>]. <italic>Virtual care</italic> is defined as “[a]ny interaction between patients and/or members of their circle of care occurring remotely, using any form of communication or information technology with the aim of facilitating or maximizing the quality of patient care.“ <italic>Secure messaging</italic> is a virtual care modality defined as “the asynchronous exchange of information between providers and patients, or between providers, through electronic platforms (e.g. texting, e-mail) that adhere to the standards of safety and privacy” [<xref ref-type="bibr" rid="ref6">6</xref>]. Effective diabetes treatment involving the tracking and monitoring of diet, blood sugar, and physical activities that involve using technology together with active treatment is shown to be cost-effective in reducing complications. The provision of remote health care services by using a variety of virtual care tools is identified by Diabetes Canada as a delivery mechanism that can improve patient outcomes by providing timely and interdisciplinary care [<xref ref-type="bibr" rid="ref3">3</xref>]. In contrast with other outcomes of conventional diabetes treatment, the use of virtual care offers benefits, such as improved access to services in rural or remote areas, reduced wait times, the avoidance of clinician and patient travel, cost efficiencies, and even reduced carbon emissions [<xref ref-type="bibr" rid="ref3">3</xref>,<xref ref-type="bibr" rid="ref7">7</xref>,<xref ref-type="bibr" rid="ref8">8</xref>]. It is unclear to what extent the use of virtual care technology in health care helps to facilitate or maximize the quality of care for patients.</p>
      <p>Our preliminary literature scan found many studies on the use of one or another form of digital health technology (telehealth, telemedicine, telemonitoring, videoconferencing, SMS text messages, electronic health records, etc) to improve diabetes management and patient outcomes, but only a small proportion are on the use of secure messaging for diabetes management. Similar findings were also suggested by a scoping review on the costs and benefits of eHealth applications that support the independent living of older adults [<xref ref-type="bibr" rid="ref9">9</xref>]. A literature scan on virtual care evaluations, which was conducted by the Canadian Agency for Drugs and Technologies in Health in 2021, noted that studies tend to assess combined virtual care modalities (eg, video and telephone), making it difficult to provide informative evidence on the impact of a specific modality [<xref ref-type="bibr" rid="ref10">10</xref>].</p>
      <p>There is some evidence suggesting that the use of virtual care technology in the management of diabetes and other chronic diseases is associated with positive clinical outcomes that, in some cases, are comparable to those of in-person care [<xref ref-type="bibr" rid="ref11">11</xref>-<xref ref-type="bibr" rid="ref15">15</xref>]. Moreover, the use of asynchronous electronic communications tools is shown to improve primary care providers’ access to specialists, minimize unnecessary referrals, and reduce call volumes to providers [<xref ref-type="bibr" rid="ref3">3</xref>,<xref ref-type="bibr" rid="ref16">16</xref>-<xref ref-type="bibr" rid="ref19">19</xref>]. However, negative impacts on clinicians' workloads and mixed inconclusive impacts on certain clinical outcomes (eg, blood pressure and cholesterol) and aspects of the quality of care have also been reported [<xref ref-type="bibr" rid="ref11">11</xref>,<xref ref-type="bibr" rid="ref15">15</xref>,<xref ref-type="bibr" rid="ref19">19</xref>-<xref ref-type="bibr" rid="ref22">22</xref>].</p>
      <p>We find that literature on the impact of secure messaging in diabetes management tends to focus on discrete outcomes, such as biomedical outcomes, cost, adoption, patient satisfaction, and workflows, among others. We posit that there is a research gap on studies that assess the impact of secure messaging in primary care through a more holistic quality of care lens (ie, safety, effectiveness, efficiency, timeliness, and patient centricity, as defined by the Institute of Medicine [<xref ref-type="bibr" rid="ref23">23</xref>]). A recent systematic review of patient portal functionalities and outcomes of patients with diabetes also identified similar gaps and the need for further studies to understand how the use of patient portals by patients with diabetes improves health outcomes [<xref ref-type="bibr" rid="ref15">15</xref>].</p>
      <p>To continue investing in virtual care services, health care policy makers need evidence on both the clinical outcomes and the health system outcomes to inform their decisions. The purpose of our scoping review is to explore what is known about the use of secure messaging in the treatment of diabetes within the primary care setting and how its impact has been assessed from the patient, health system, and quality of care perspectives.</p>
      <p>Our scoping review will contribute to existing literature by examining the literature for evidence on the impact of secure messaging in the treatment of diabetes from a more holistic quality of care perspective that includes both clinical outcomes and health system outcomes.</p>
    </sec>
    <sec sec-type="methods">
      <title>Methods</title>
      <sec>
        <title>Study Design</title>
        <p>Our review will be based on the Arksey and O’Malley methodological framework for scoping reviews, which includes the following six steps: (1) identifying the research question; (2) identifying the relevant studies; (3) defining the study selection criteria; (4) charting the data; (5) collating, summarizing, and reporting the results; and (6) optionally consulting with peers for additional feedback and the validation of findings [<xref ref-type="bibr" rid="ref24">24</xref>].</p>
        <p>Our approach will result in the wide coverage of the literature. The decision to narrow down the literature will be made once the reviewers have a sense of the volume and general scope of the literature and gain familiarity with the literature and the field, after conducting the search [<xref ref-type="bibr" rid="ref24">24</xref>]. The tools recommended by Levac et al [<xref ref-type="bibr" rid="ref25">25</xref>] and the Joanna Briggs Institute [<xref ref-type="bibr" rid="ref26">26</xref>-<xref ref-type="bibr" rid="ref28">28</xref>], which are grounded on Arksey and O’Malley’s [<xref ref-type="bibr" rid="ref24">24</xref>] earlier work, will be leveraged to conduct and report our scoping review in a structured way. These tools include the Population, Concept, and Context (PCC) framework and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines and checklist.</p>
      </sec>
      <sec>
        <title>Stage 1: Identifying the Research Question</title>
        <p>Our scoping review aims to address the following research questions:</p>
        <list list-type="order">
          <list-item>
            <p>How is secure messaging used in the treatment of diabetes within the primary care setting?</p>
          </list-item>
          <list-item>
            <p>Which outcome measures are used?</p>
          </list-item>
          <list-item>
            <p>What is the impact of using secure messaging on the quality of care?</p>
          </list-item>
          <list-item>
            <p>What are the facilitators, risks, and challenges of adopting secure messaging for diabetes care?</p>
          </list-item>
        </list>
      </sec>
      <sec>
        <title>Stage 2: Identifying Relevant Studies</title>
        <p>The PCC framework was utilized to identify the main concepts of the research questions (<xref ref-type="table" rid="table1">Table 1</xref>). Initial iterative searches in MEDLINE were conducted by the principal investigator (AL) to identify relevant articles and subject headings.</p>
        <table-wrap position="float" id="table1">
          <label>Table 1</label>
          <caption>
            <p>Population, Concept, and Context framework and search terms.</p>
          </caption>
          <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
            <col width="160"/>
            <col width="260"/>
            <col width="270"/>
            <col width="310"/>
            <thead>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Main concept keywords</td>
                <td>Alternative keywords</td>
                <td>Medical Subject Headings</td>
              </tr>
            </thead>
            <tbody>
              <tr valign="top">
                <td>Participants</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>
                        <italic>diabetic patients</italic>
                      </p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>
                        <italic>Diabetes Mellitus</italic>
                      </p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>
                        <italic>Diabetes Mellitus</italic>
                      </p>
                    </list-item>
                  </list>
                </td>
              </tr>
              <tr valign="top">
                <td>Concept</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>
                        <italic>secure message</italic>
                      </p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>
                        <italic>secure messaging</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>secure communication</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>secure email</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>virtual care</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>virtual health</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>telehealth</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>telemedicine</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>e-visits data</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>mhealth</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>patient portal</italic>
                      </p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>
                        <italic>Electronic Health Records</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Communication</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Telemedicine</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Patient portal</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Personal Health Records</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Computerized Medical Records Systems</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Electronic Mail</italic>
                      </p>
                    </list-item>
                  </list>
                </td>
              </tr>
              <tr valign="top">
                <td>Context</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>
                        <italic>Primary healthcare setting</italic>
                      </p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>
                        <italic>Primary care setting</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Community setting</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Outpatient setting</italic>
                      </p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>
                        <italic>Primary Health Care</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Community Health Services</italic>
                      </p>
                    </list-item>
                    <list-item>
                      <p>
                        <italic>Outpatient</italic>
                      </p>
                    </list-item>
                  </list>
                </td>
              </tr>
            </tbody>
          </table>
        </table-wrap>
        <p>Further iterative searches against MEDLINE were conducted in collaboration with a professional information specialist, resulting in a more refined search strategy that produced 4972 results (<xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref>). This search strategy was then submitted to a second information specialist for a peer review assessment and the validation of the quality and comprehensiveness of the search strategy, in accordance with the PRESS (Peer Review of Electronic Search Strategies) 2015 guideline [<xref ref-type="bibr" rid="ref29">29</xref>]. Comments were reviewed, and adjustments were made to the strategy as deemed appropriate.</p>
        <p>The intervention of interest is secure messaging use in the treatment of diabetes within primary care settings. The care settings will comprise noninstitutionalized and nonhospital settings. This aligns with the definitions of <italic>primary care</italic> by the World Health Organization [<xref ref-type="bibr" rid="ref30">30</xref>] and Health Canada, whereby primary care is considered an “element within primary health care that focusses on health care services, including health promotion, illness and injury prevention, and the diagnosis and treatment of illness and injury” [<xref ref-type="bibr" rid="ref31">31</xref>].</p>
        <p>Our strategy utilizes a combination of controlled vocabulary (eg, <italic>Diabetes Mellitus</italic>, <italic>Telemedicine</italic>, and <italic>Patient Portals</italic>) and free-text terms (eg, <italic>NIDDM</italic>, <italic>virtual consult</italic>, and <italic>secure email</italic>). Using the Ovid platform, we will search Ovid MEDLINE ALL, Embase, and APA PsycINFO. We will also search the Cochrane Library on Wiley, CINAHL on EBSCO, and PubMed. Vocabulary and syntax will be adjusted across the databases. No language or date limits will be applied, but animal-only records will be removed where possible. Results will be downloaded and deduplicated by using EndNote 9.3.3 (Clarivate Plc) and uploaded to Covidence (Veritas Health Innovation Ltd).</p>
        <p>The reference lists of all included studies will also be hand searched to identify additional literature that may not be captured through the database search. Additional grey literature will also be identified through an existing network of reviewers, relevant journals, organizations, conferences, and a community of practices across the globe. EndNote software will be utilized to manage references.</p>
      </sec>
      <sec>
        <title>Stage 3: Defining the Study Selection Criteria</title>
        <p>Based on the research questions and objectives, the inclusion and exclusion criteria shown in <xref ref-type="table" rid="table2">Table 2</xref> will be used to initially guide the review. The further refinement of these criteria will occur in an iterative manner as the reviewers gain a better understanding of the scope of available literature. In alignment with the PCC framework, the initial inclusion criteria will include those for the population (patients with diabetes), concept (secure messages), and context (primary and community care settings). The use of secure messaging for patient-provider, caregiver-provider, and provider-provider communications will be included. The initial exclusion criteria will be patients with gestational diabetes, other virtual or digital health interventions, and institutionalized or hospital settings.</p>
        <table-wrap position="float" id="table2">
          <label>Table 2</label>
          <caption>
            <p>Inclusion and exclusion criteria.</p>
          </caption>
          <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
            <col width="200"/>
            <col width="400"/>
            <col width="400"/>
            <thead>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Inclusion criteria</td>
                <td>Exclusion criteria</td>
              </tr>
            </thead>
            <tbody>
              <tr valign="top">
                <td>Year of publication</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>No limit</p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>N/A<sup>a</sup></p>
                    </list-item>
                  </list>
                </td>
              </tr>
              <tr valign="top">
                <td>Language</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>English</p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>All other languages</p>
                    </list-item>
                  </list>
                </td>
              </tr>
              <tr valign="top">
                <td>Population</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>Patients with diabetes (types 1 and 2)</p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>Patients with gestational diabetes</p>
                    </list-item>
                  </list>
                </td>
              </tr>
              <tr valign="top">
                <td>Concept or intervention</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>Secure message</p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>Other virtual care modalities (videoconferences and phone calls)</p>
                    </list-item>
                  </list>
                </td>
              </tr>
              <tr valign="top">
                <td>Context and setting</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>Primary health care setting</p>
                    </list-item>
                    <list-item>
                      <p>Primary care setting</p>
                    </list-item>
                    <list-item>
                      <p>Outpatient setting</p>
                    </list-item>
                    <list-item>
                      <p>Community setting</p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>Hospital setting</p>
                    </list-item>
                    <list-item>
                      <p>Inpatient setting</p>
                    </list-item>
                    <list-item>
                      <p>Institutionalized treatment within acute care setting</p>
                    </list-item>
                  </list>
                </td>
              </tr>
              <tr valign="top">
                <td>Study design</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>Studies that contain defined impacts and outcomes of secure messaging for diabetes treatment</p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>Studies that do not contain defined impacts of secure messaging for diabetes treatment</p>
                    </list-item>
                    <list-item>
                      <p>Commentaries</p>
                    </list-item>
                    <list-item>
                      <p>Opinions</p>
                    </list-item>
                    <list-item>
                      <p>Summary articles</p>
                    </list-item>
                    <list-item>
                      <p>Clinical trial recruitments</p>
                    </list-item>
                    <list-item>
                      <p>Scoping or systematic review protocols</p>
                    </list-item>
                    <list-item>
                      <p>Abstracts</p>
                    </list-item>
                  </list>
                </td>
              </tr>
              <tr valign="top">
                <td>Outcomes</td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>All patient-related clinical outcomes and health system outcomes (eg, patient experience, patient clinical outcomes, health system outcomes, health care utilization, quality of life outcomes, health status, emergency room visits, follow-up visits, etc)</p>
                    </list-item>
                  </list>
                </td>
                <td>
                  <list list-type="bullet">
                    <list-item>
                      <p>Nonclinical outcomes and outcomes unrelated to health systems</p>
                    </list-item>
                  </list>
                </td>
              </tr>
            </tbody>
          </table>
          <table-wrap-foot>
            <fn id="table2fn1">
              <p><sup>a</sup>N/A: not applicable.</p>
            </fn>
          </table-wrap-foot>
        </table-wrap>
      </sec>
      <sec>
        <title>Stage 4: Charting the Data</title>
        <p>The review team consists of the following three reviewers: the principal investigator (AL), the supervisor (DM), and the cosupervisor (TS). Due to its convenience, Covidence will be used by the reviewers to independently screen the articles, based on the inclusion and exclusion criteria, in the following two steps: (1) title and abstract review and (2) full-text review of the full-text articles and documents. To be more inclusive and reduce the risk of excluding relevant studies, any articles that reviewers are unsure of during the title and abstract scan will be moved forward to the full-text review stage.</p>
        <p>Data extraction will be conducted outside of Covidence, using a charting form (<xref ref-type="supplementary-material" rid="app2">Multimedia Appendix 2</xref>) that we initially created based on Arksey and O’Malley’s [<xref ref-type="bibr" rid="ref24">24</xref>] recommendations, which include the following elements: author(s), year of publication, study location, intervention type, comparator (if any), duration of the intervention, study populations, aims of the study, methodology, outcome measures, and important results.</p>
        <p>Two reviewers will pilot the data extraction form on the first 30 articles to identify the need for modification. The review team will further revise the form, as needed, during the data extraction process as new relevant data types and themes are encountered.</p>
      </sec>
      <sec>
        <title>Stage 5: Collating, Summarizing, and Reporting the Results</title>
        <p>The review team will utilize the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) chart and PRISMA-ScR checklist [<xref ref-type="bibr" rid="ref27">27</xref>] to report their findings in a clear, transparent way (<xref ref-type="supplementary-material" rid="app3">Multimedia Appendix 3</xref> [<xref ref-type="bibr" rid="ref28">28</xref>] and <xref ref-type="supplementary-material" rid="app4">Multimedia Appendix 4</xref> [<xref ref-type="bibr" rid="ref27">27</xref>]).</p>
        <p>A narrative summary of findings will be developed based on the elements of the data extraction form and guided by the context of the research question and study objectives. Throughout the course of the review, if other criteria or elements are uncovered, the authors will decide on other additional formats (eg, graphs, tables, and diagrams) for presenting the study findings.</p>
      </sec>
      <sec>
        <title>Stage 6: Peer Consultation for Feedback and Validation</title>
        <p>At different stages, experts will be consulted to review and provide feedback. In stage 2, prior to executing the final search, the search strategy will undergo a peer review by a qualified librarian to ensure relevance and achieve more holistic search results. Other experts within the field will also be drawn from our networks to ensure that relevant findings are captured and reported in a clear manner. In stages 3 to 5, experts will also be consulted to suggest additional literature and provide feedback on the data extraction form.</p>
        <p>The experts we consult will include researchers and practitioners within the digital health field and decision makers from publicly funded payer organizations.</p>
      </sec>
      <sec>
        <title>Ethical Considerations</title>
        <p>Neither ethics approval nor participant consent is required, as our scoping review will not include human or animal participants. Data will be collected from published literature.</p>
      </sec>
    </sec>
    <sec sec-type="results">
      <title>Results</title>
      <p>The systematic literature search of databases has been conducted, and the title and abstract review is planned to commence in early September 2022.</p>
      <p>An article of the scoping review findings will be submitted for publication in a peer-reviewed journal. The final version of findings and the full-text article will be shared with a panel and wider stakeholder organizations.</p>
    </sec>
    <sec sec-type="discussion">
      <title>Discussion</title>
      <sec>
        <title>Overview</title>
        <p>Our scoping review will explore what is known about the use of secure messaging in the treatment of diabetes within the primary care setting. The review will contribute to knowledge on this topic by examining how the impact of secure messaging has been assessed from the patient, health system, and quality of care perspectives. To our knowledge, this has not been the focus of previous reviews [<xref ref-type="bibr" rid="ref11">11</xref>,<xref ref-type="bibr" rid="ref15">15</xref>,<xref ref-type="bibr" rid="ref22">22</xref>,<xref ref-type="bibr" rid="ref23">23</xref>].</p>
        <p>The findings of the scoping review will inform health care policy makers’ decisions on virtual care services.</p>
      </sec>
      <sec>
        <title>Strengths and Limitations</title>
        <p>Our scoping review will use an established framework and a comprehensive systematic search to identify and review existing literature on the use of secure messaging in the treatment of diabetes to date. The search strategy is peer-reviewed, and the grey literature search and the review will be informed and guided via consultation with experts. Although the findings will be useful in understanding the state of the literature and potential research gaps, the study does not aim to conduct a full assessment of the quality of the evidence in the literature uncovered.</p>
      </sec>
    </sec>
  </body>
  <back>
    <app-group>
      <supplementary-material id="app1">
        <label>Multimedia Appendix 1</label>
        <p>Search strategy.</p>
        <media xlink:href="resprot_v12i1e42339_app1.docx" xlink:title="DOCX File , 21 KB"/>
      </supplementary-material>
      <supplementary-material id="app2">
        <label>Multimedia Appendix 2</label>
        <p>Data extraction form.</p>
        <media xlink:href="resprot_v12i1e42339_app2.docx" xlink:title="DOCX File , 24 KB"/>
      </supplementary-material>
      <supplementary-material id="app3">
        <label>Multimedia Appendix 3</label>
        <p>PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 flow diagram template [<xref ref-type="bibr" rid="ref28">28</xref>].</p>
        <media xlink:href="resprot_v12i1e42339_app3.docx" xlink:title="DOCX File , 66 KB"/>
      </supplementary-material>
      <supplementary-material id="app4">
        <label>Multimedia Appendix 4</label>
        <p>PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist [<xref ref-type="bibr" rid="ref27">27</xref>].</p>
        <media xlink:href="resprot_v12i1e42339_app4.docx" xlink:title="DOCX File , 109 KB"/>
      </supplementary-material>
    </app-group>
    <glossary>
      <title>Abbreviations</title>
      <def-list>
        <def-item>
          <term id="abb1">PCC</term>
          <def>
            <p>Population, Concept, and Context</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb2">PRESS</term>
          <def>
            <p>Peer Review of Electronic Search Strategies</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb3">PRISMA</term>
          <def>
            <p>Preferred Reporting Items for Systematic Reviews and Meta-Analyses</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb4">PRISMA-ScR</term>
          <def>
            <p>Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews</p>
          </def>
        </def-item>
      </def-list>
    </glossary>
    <ack>
      <p>The study design, conceptualization, and manuscript were developed by AL, under the supervision of DM and TS, who reviewed and approved the draft and final version of the review protocol. EA reviewed the draft and provided input and feedback on research objectives, definitions of key terms, and accompanying literature sources.</p>
      <p>The authors consulted with Simon Hagen (Canada Health Infoway), who provided guidance on sources of grey literature for consideration.</p>
      <p>We thank Kaitryn Campbell, MLIS, MSc (St. Joseph’s Healthcare Hamilton/McMaster University), for peer reviewing the MEDLINE search strategy.</p>
    </ack>
    <fn-group>
      <fn fn-type="conflict">
        <p>None declared.</p>
      </fn>
    </fn-group>
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