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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">v9i2e16929</article-id>
      <article-id pub-id-type="pmid">32022694</article-id>
      <article-id pub-id-type="doi">10.2196/16929</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>Use of Apps to Promote Childhood Vaccination: Protocol for a Systematic Review</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="editor">
          <name>
            <surname>Eysenbach</surname>
            <given-names>Gunther</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Jarour</surname>
            <given-names>Najwa</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib id="contrib1" contrib-type="author">
          <name name-style="western">
            <surname>Van Velthoven</surname>
            <given-names>Michelle Helena</given-names>
          </name>
          <degrees>BSc, MSc, PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0003-1245-8759</ext-link>
        </contrib>
        <contrib id="contrib2" contrib-type="author">
          <name name-style="western">
            <surname>Milne-Ives</surname>
            <given-names>Madison</given-names>
          </name>
          <degrees>BA, MSc</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0001-7628-882X</ext-link>
        </contrib>
        <contrib id="contrib3" contrib-type="author">
          <name name-style="western">
            <surname>de Cock</surname>
            <given-names>Caroline</given-names>
          </name>
          <degrees>BSc, MSc</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0001-7585-9598</ext-link>
        </contrib>
        <contrib id="contrib4" contrib-type="author">
          <name name-style="western">
            <surname>Mooney</surname>
            <given-names>Mary</given-names>
          </name>
          <degrees>RM, RNT, RGN, MA, MSc, PhD</degrees>
          <xref rid="aff2" ref-type="aff">2</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-0689-7029</ext-link>
        </contrib>
        <contrib id="contrib5" contrib-type="author" corresp="yes">
          <name name-style="western">
            <surname>Meinert</surname>
            <given-names>Edward</given-names>
          </name>
          <degrees>MA, MSc, MBA, MPA, PhD DIC, CEng FBCS, EUR ING</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <address>
            <institution>Digitally Enabled PrevenTative Health (DEPTH) Research Group</institution>
            <institution>Department of Paediatrics</institution>
            <addr-line>University of Oxford</addr-line>
            <addr-line>Oxford</addr-line>
            <country>United Kingdom</country>
            <phone>44 7824446808</phone>
            <email>e.meinert14@imperial.ac.uk</email>
          </address>
          <xref rid="aff3" ref-type="aff">3</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0003-2484-3347</ext-link>
        </contrib>
      </contrib-group>
      <aff id="aff1">
        <label>1</label>
        <institution>Digitally Enabled PrevenTative Health (DEPTH) Research Group</institution>
        <institution>Department of Paediatrics</institution>
        <addr-line>Oxford</addr-line>
        <country>United Kingdom</country>
      </aff>
      <aff id="aff2">
        <label>2</label>
        <institution>School of Nursing &#38; Midwifery</institution>
        <institution>Trinity College Dublin</institution>
        <addr-line>Dublin</addr-line>
        <country>Ireland</country>
      </aff>
      <aff id="aff3">
        <label>3</label>
        <institution>Department of Primary Care and Public Health</institution>
        <institution>Imperial College London</institution>
        <addr-line>London</addr-line>
        <country>United Kingdom</country>
      </aff>
      <author-notes>
        <corresp>Corresponding Author: Edward Meinert <email>e.meinert14@imperial.ac.uk</email></corresp>
      </author-notes>
      <pub-date pub-type="collection">
        <month>2</month>
        <year>2020</year>
      </pub-date>
      <pub-date pub-type="epub">
        <day>5</day>
        <month>2</month>
        <year>2020</year>
      </pub-date>
      <volume>9</volume>
      <issue>2</issue>
      <elocation-id>e16929</elocation-id>
      <history>
        <date date-type="received">
          <day>6</day>
          <month>11</month>
          <year>2019</year>
        </date>
        <date date-type="accepted">
          <day>28</day>
          <month>11</month>
          <year>2019</year>
        </date>
      </history>
      <copyright-statement>©Michelle Helena Van Velthoven, Madison Milne-Ives, Caroline de Cock, Mary Mooney, Edward Meinert. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.02.2020.</copyright-statement>
      <copyright-year>2020</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 http://www.researchprotocols.org, as well as this copyright and license information must be included.</p>
      </license>
      <self-uri xlink:href="https://www.researchprotocols.org/2020/2/e16929" xlink:type="simple"/>
      <abstract>
        <sec sec-type="background">
          <title>Background</title>
          <p>The decline in the uptake of routine childhood vaccinations has resulted in outbreaks of vaccine-preventable diseases. Vaccination apps can be used as a tool to promote immunization through the provision of reminders, dissemination of information, peer support, and feedback.</p>
        </sec>
        <sec sec-type="objective">
          <title>Objective</title>
          <p>The aim of this review is to systematically review the evidence on the use of apps to support childhood vaccination uptake, information storage, and record sharing.</p>
        </sec>
        <sec sec-type="methods">
          <title>Methods</title>
          <p>We will identify relevant papers by searching the following electronic databases: PubMed, Embase by Ovid, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov, and Education Resources Information Center (ERIC). We will review the reference lists of those studies that we include to identify relevant additional papers not initially identified using our search strategy. In addition to the use of electronic databases, we will search for grey literature on the topic. The search strategy will include only terms relating to or describing the intervention, which is app use. As almost all titles and abstracts are in English, 100% of these will be reviewed, but retrieval will be confined to papers written in the English language. We will record the search outcome on a specifically designed record sheet. Two reviewers will select observational and intervention studies, appraise the quality of the studies, and extract the relevant data. All studies will involve the use of apps relating to child vaccinations. The primary outcome is the uptake of vaccinations. Secondary outcomes are as follows: (1) use of app for sharing of information and providing vaccination reminders and (2) use of app for storage of vaccination information; knowledge and decision making by parents regarding vaccination (ie, risks and benefits of vaccination); costs and cost-effectiveness of vaccination apps; use of the app and measures of usability (eg, usefulness, acceptability, and experiences of different users: parents and  health care professionals); use of technical standards for development of the app; and adverse events (eg, data leaks and misinformation). We will exclude studies that do not study an app. We anticipate a limited scope for meta-analysis and will provide a narrative overview of findings and tabular summaries of extracted data.</p>
        </sec>
        <sec sec-type="results">
          <title>Results</title>
          <p>This project was funded by the Sir David Cooksey Fellowship in Healthcare Translation at the University of Oxford, Oxford, United Kingdom. We will submit the full systematic review for publication in the <italic>Journal of Medical Internet Research</italic>.</p>
        </sec>
        <sec sec-type="conclusions">
          <title>Conclusions</title>
          <p>This review will follow, where possible, the Cochrane Collaboration and the Centre for Review and Dissemination methodologies for conducting systematic reviews. We will report our findings based on guidelines from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The review results will be used to inform the development of a vaccination app.</p>
        </sec>
        <sec sec-type="registered-report">
          <title>International Registered Report Identifier (IRRID)</title>
          <p>PRR1-10.2196/16929</p>
        </sec>
      </abstract>
      <kwd-group>
        <kwd>app</kwd>
        <kwd>smartphone technology</kwd>
        <kwd>vaccination</kwd>
        <kwd>vaccines</kwd>
        <kwd>immunization</kwd>
        <kwd>children</kwd>
        <kwd>mobile phone</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec sec-type="introduction">
      <title>Introduction</title>
      <sec>
        <title>Description of the Issue</title>
        <p>Outbreaks of vaccine-preventable diseases, such as the measles, mumps, rubella, and diphtheria, have risen over the past decade [<xref ref-type="bibr" rid="ref1">1</xref>-<xref ref-type="bibr" rid="ref3">3</xref>]. While mortality rates of vaccine-preventable diseases are relatively low, certain groups, including children under 5 years of age and people with a compromised immune system, are at greater risk of severe complications [<xref ref-type="bibr" rid="ref2">2</xref>]. The decline in the uptake of routine childhood vaccinations has been identified as a cause for outbreaks of vaccine-preventable diseases. Immunization coverage has declined for nine routine childhood vaccinations measured at different child ages in England; vaccination rates fell by 0.2%-1% in 2018-2019 compared to the previous year [<xref ref-type="bibr" rid="ref4">4</xref>].</p>
        <p>There are numerous interrelated reasons for the decline in childhood vaccinations, including concerns about side effects, fear of autism, objection against many injections, moral or religious grounds, costs, access, and other reasons [<xref ref-type="bibr" rid="ref3">3</xref>]. A commonly mentioned reason is misinformation and false evidence, for example, claims by the discredited ex-physician Andrew Wakefield who linked the measles, mumps, and rubella (MMR) vaccine to autism in 1998 [<xref ref-type="bibr" rid="ref5">5</xref>]. Religious and philosophical reasons have been used by certain groups to decline vaccination of their children [<xref ref-type="bibr" rid="ref6">6</xref>]. Particular communities have been consistently difficult to engage, for example, male-dominated societies often resist vaccination against human papillomavirus (HPV) [<xref ref-type="bibr" rid="ref7">7</xref>,<xref ref-type="bibr" rid="ref8">8</xref>]. The seriousness and relative rarity of these illnesses has reduced some people’s awareness of the importance of vaccination. Visiting a health clinic for vaccinations might be an inconvenience or may also be forgotten about [<xref ref-type="bibr" rid="ref3">3</xref>], particularly as reminders to attend a clinic for vaccinations are not part of routine health care in all countries.</p>
      </sec>
      <sec>
        <title>Description of the Intervention</title>
        <p>There have been several initiatives to improve the uptake of childhood vaccinations in different settings [<xref ref-type="bibr" rid="ref9">9</xref>,<xref ref-type="bibr" rid="ref10">10</xref>]. These include a range of informational, behavioral, and environmental initiatives. Health care provider initiatives have focused on patient counseling, maximizing the opportunities of each visit, combination vaccines, and automated electronic patient record reminders. Community-based approaches to increase vaccination rates include increasing outreach and educational programs, using recall and reminder strategies, providing financial incentives, and offering vaccinations at nontraditional sites [<xref ref-type="bibr" rid="ref3">3</xref>].</p>
        <p>Over the past decade, public and private organizations have developed tools to improve vaccination coverage, including vaccination information websites and apps [<xref ref-type="bibr" rid="ref11">11</xref>]. These apps help health care providers and patients to access reminders for recommended immunization schedules and related vaccine resources and websites; they also allow for changes in the schedules through app updates.</p>
      </sec>
      <sec>
        <title>How the Intervention Might Work</title>
        <p>Vaccination apps can be used as a tool to provide reminders, information, peer support, and feedback [<xref ref-type="bibr" rid="ref12">12</xref>]. A cluster randomized controlled trial showed that an app used by village doctors, which included text messages to caregivers, improved full vaccination coverage in China. Village doctors using the app reported improved efficiency in managing childhood vaccinations [<xref ref-type="bibr" rid="ref13">13</xref>]. A quasi-experimental pre-post study using an app to electronically register child births and sending text message reminders to parents about upcoming vaccinations showed improved vaccination coverage in rural hard-to-reach and urban street dweller communities in Bangladesh [<xref ref-type="bibr" rid="ref14">14</xref>].</p>
      </sec>
      <sec>
        <title>Why It Is Important to Do This Review</title>
        <p>A systematic review that assessed interventions to improve immunization coverage in England concluded that current practice is insufficient [<xref ref-type="bibr" rid="ref15">15</xref>]. Vaccination apps might be used to help improve immunization coverage but, to our knowledge, no recent systematic reviews have assessed the evidence on childhood vaccination apps. A systematic review on the design of a vaccination reminder app identified two publications on mobile apps, but the search was limited and conducted in 2015 [<xref ref-type="bibr" rid="ref12">12</xref>]. Furthermore, this review did not assess all important quality indicators, including whether the app was secure, usable, engaging, efficacious, and cost-effective [<xref ref-type="bibr" rid="ref16">16</xref>].</p>
      </sec>
      <sec>
        <title>Objective</title>
        <p>Our objective is to systematically review the evidence on childhood vaccination apps by assessing the following:</p>
        <list list-type="order">
          <list-item>
            <p>The uptake of vaccination.</p>
          </list-item>
          <list-item>
            <p>Knowledge and decision making by parents: risks and benefits of vaccination.</p>
          </list-item>
          <list-item>
            <p>Costs and cost-effectiveness.</p>
          </list-item>
          <list-item>
            <p>Use of the app and measures of usability (eg, usefulness, acceptability, and experiences of different users: parents and health care professionals).</p>
          </list-item>
          <list-item>
            <p>Use of technical standards for development of the app.</p>
          </list-item>
          <list-item>
            <p>Adverse events (eg, data leaks and misinformation).</p>
          </list-item>
        </list>
      </sec>
    </sec>
    <sec sec-type="methods">
      <title>Methods</title>
      <sec>
        <title>Overview</title>
        <p>This is the protocol for a systematic review of the literature that will be reported, where possible, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols (PRISMA-P), as provided in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref> [<xref ref-type="bibr" rid="ref17">17</xref>]. Our review will follow, where possible, the Cochrane Collaboration [<xref ref-type="bibr" rid="ref18">18</xref>] and the Centre for Review and Dissemination [<xref ref-type="bibr" rid="ref19">19</xref>] methodologies for conducting systematic reviews.</p>
      </sec>
      <sec>
        <title>Criteria for Considering Studies</title>
        <sec>
          <title>Types of Studies</title>
          <p>We will include observational studies, such as cross-sectional surveys, cohort studies, qualitative studies (eg, interview studies and focus groups), and intervention studies, such as randomized controlled trials and nonrandomized studies (eg, nonrandomized controlled trials, before-and-after studies, and interrupted-time-series studies). We will only include studies reported in English and published after 2008, when the first smartphone was launched.</p>
        </sec>
        <sec>
          <title>Types of Participants</title>
          <p>We will include studies involving children up to 18 years of age, the children’s parents or guardians, and health care providers in any country. We will exclude studies focusing on vaccination of adults.</p>
        </sec>
        <sec>
          <title>Types of Interventions</title>
          <p>We will include any studies assessing apps designed to support childhood vaccination uptake, information storage, and record sharing (see <xref ref-type="table" rid="table1">Table 1</xref>). We will exclude studies that do not involve the use or study of an app for childhood vaccinations and that solely focus on other ways of delivering vaccination interventions, such as text messaging, telephone calls, or a website [<xref ref-type="bibr" rid="ref20">20</xref>,<xref ref-type="bibr" rid="ref21">21</xref>].</p>
          <table-wrap position="float" id="table1">
            <label>Table 1</label>
            <caption>
              <p>Childhood immunization schedule: Ireland example.</p>
            </caption>
            <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
              <col width="150"/>
              <col width="200"/>
              <col width="650"/>
              <thead>
                <tr valign="top">
                  <td>Child’s age</td>
                  <td>Where vaccination is given</td>
                  <td>Vaccine</td>
                </tr>
              </thead>
              <tbody>
                <tr valign="top">
                  <td>Birth</td>
                  <td>Hospital or clinic</td>
                  <td>Bacille Calmette-Guerin (BCG) vaccine: a vaccine to protect against tuberculosis disease</td>
                </tr>
                <tr valign="top">
                  <td>2 months</td>
                  <td>General practitioner</td>
                  <td>6 in 1: vaccines against diphtheria, tetanus, whooping cough (ie, pertussis), polio, <italic>Haemophilus influenzae</italic> type b (Hib), and hepatitis B provided in one single injection<break/>Vaccines against pneumococcal disease, meningococcal B, and rotavirus disease</td>
                </tr>
                <tr valign="top">
                  <td>4 months</td>
                  <td>General practitioner</td>
                  <td>6 in 1: vaccines against diphtheria, tetanus, whooping cough (ie, pertussis), polio, <italic>Haemophilus influenzae</italic> type b (Hib), and hepatitis B provided in one single injection<break/>Vaccines against meningococcal B and rotavirus disease</td>
                </tr>
                <tr valign="top">
                  <td>6 months</td>
                  <td>General practitioner</td>
                  <td>6 in 1: vaccines against diphtheria, tetanus, whooping cough (ie, pertussis), polio, <italic>Haemophilus influenzae</italic> type b (Hib), and hepatitis B provided in one single injection<break/>Vaccines against pneumococcal disease and meningococcal C</td>
                </tr>
                <tr valign="top">
                  <td>12 months</td>
                  <td>General practitioner</td>
                  <td>Measles, mumps, and rubella (MMR) vaccine<break/>Vaccine against meningococcal B</td>
                </tr>
                <tr valign="top">
                  <td>13 months</td>
                  <td>General practitioner</td>
                  <td>Vaccines against meningococcal C, <italic>Haemophilus influenzae</italic> type b (Hib), and pneumococcal disease</td>
                </tr>
                <tr valign="top">
                  <td>4-5 years</td>
                  <td>General practitioner or school</td>
                  <td>4 in 1: vaccines against diphtheria, tetanus, whooping cough (ie, pertussis), and polio<break/>Measles, mumps, and rubella (MMR) vaccine</td>
                </tr>
                <tr valign="top">
                  <td>11-14 years</td>
                  <td>School</td>
                  <td>Tetanus and low-dose diphtheria and pertussis (Tdap) booster<break/>Meningococcal C booster<break/>Human papillomavirus (HPV) vaccine (2 doses)</td>
                </tr>
              </tbody>
            </table>
          </table-wrap>
        </sec>
        <sec>
          <title>Types of Comparators</title>
          <p>We will include any type of comparator interventions.</p>
        </sec>
        <sec>
          <title>Types of Outcome Measures</title>
          <p>The primary outcome of this review is the uptake of vaccination. Secondary outcomes are knowledge and decision making by parents (ie, risks and benefits of vaccination); costs and cost-effectiveness; use of the app and measures of usability (eg, usefulness, acceptability, and experiences of different users: parents and health care professionals); use of technical standards for development of the app; and adverse events (eg, data leaks and misinformation).</p>
        </sec>
      </sec>
      <sec>
        <title>Information Sources</title>
        <p>Relevant articles will be identified by searching the following electronic databases: (1) PubMed, (2), Embase through Ovid, (3) Web of Science, (4) Cochrane Central Register of Controlled Trials (CENTRAL) [<xref ref-type="bibr" rid="ref22">22</xref>], (5) ClinicalTrials.gov, and (6) Education Resources Information Center (ERIC).</p>
      </sec>
      <sec>
        <title>Search Strategy</title>
        <p>A draft search strategy can be found in <xref ref-type="supplementary-material" rid="app1">Multimedia Appendix 1</xref>. This will be tailored to the different databases, with the assistance of a medical research librarian. No study design filter will be used, as both quantitative and qualitative studies are to be included. We will use the titles, abstracts, and keywords of a set of articles that we know meet our inclusion criteria to define a search strategy that will return all these articles without an unmanageably large number of irrelevant articles.</p>
      </sec>
      <sec>
        <title>Data Management, Collection, and Analysis</title>
        <sec>
          <title>Selection of Studies</title>
          <p>Studies that meet the inclusion criteria will be included in the review. Two reviewers will screen titles and abstracts against the inclusion and exclusion criteria. Where duplicates or publications from the same study are identified, articles will be screened and the more recent publication or the one with the most detail will be selected for inclusion in the review. Two reviewers will assess full texts for eligibility; any disagreement will be resolved through discussion with a third reviewer. Study selection will be demonstrated using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart.</p>
        </sec>
        <sec>
          <title>Data Extraction</title>
          <p>We will pilot the data extraction form on a small number of studies to develop the final data extraction form. One reviewer will extract data from the included studies, which will be validated by a second reviewer. The data extraction form will be based on the minimum requirements as recommended by the Cochrane Handbook for Systematic Reviews of Interventions [<xref ref-type="bibr" rid="ref18">18</xref>]. The data extraction form will be comprised of a Microsoft Excel form and will include the following about the studies: general information (eg, title, authors, and date); characteristics (eg, study design, aim, duration, and inclusion and exclusion criteria); risk of bias, depending on study design; samples (eg, description, geographic location, and setting); interventions; outcomes, as specified above; and results (eg, outcomes and times of assessment).</p>
        </sec>
        <sec>
          <title>Assessment of Methodological Quality and Risk of Bias</title>
          <p>Quality assessment will be undertaken by two reviewers. Any disagreements will be resolved by consensus and by including the opinion of a third reviewer. The methods specified in the Cochrane Collaboration’s tool for assessing risk of bias will be used. Three bias assessment categories will be used: low, high, and unclear risk, as specified in the Cochrane Handbook for Systematic Reviews of Interventions [<xref ref-type="bibr" rid="ref18">18</xref>]; as specified in this handbook [<xref ref-type="bibr" rid="ref18">18</xref>], an adapted version of these domains will also be used for nonrandomized studies. For other types of studies, we will use adapted versions of the following: Cochrane’s Risk Of Bias In Non-randomized Studies-of Interventions (ROBINS-I) tool [<xref ref-type="bibr" rid="ref23">23</xref>], the Critical Appraisal Skills Programme (CASP) tool for qualitative studies [<xref ref-type="bibr" rid="ref24">24</xref>], and the Appraisal tool for Cross-Sectional Studies (AXIS) [<xref ref-type="bibr" rid="ref25">25</xref>].</p>
        </sec>
        <sec>
          <title>Assessment of Heterogeneity</title>
          <p>We anticipate a limited scope for meta-analysis due to differences in study populations, interventions, and outcomes. If a sufficient number of studies are found, we will explore heterogeneity through consideration of the study populations, methods, and interventions by visual inspection of results. Also, in statistical terms, we will assess the chi-square test for homogeneity and the I<sup>2</sup> statistic. We will define statistically significant heterogeneity as <italic>P</italic>&#60;.10. The I<sup>2</sup> will be assessed with the following levels of inconsistency: I<sup>2</sup> of 0%-25% represents a low level of inconsistency; I<sup>2</sup> of 26%-50% represents a moderate level of inconsistency; and I<sup>2</sup>&#62;50% represents a high level of inconsistency.</p>
        </sec>
        <sec>
          <title>Data Synthesis</title>
          <p>If a meta-analysis is not possible, we will provide a narrative overview of the findings and tabular summaries of extracted data. If a meta-analysis can be performed, this will allow us to estimate a summary measure of effect on relevant outcomes. For dichotomous outcomes, odds ratios will be used as the summary statistic. For continuous outcomes, mean difference will be the summary statistic. Standard pairwise meta-analysis will be conducted when more than one randomized controlled trial is identified.</p>
        </sec>
        <sec>
          <title>Subgroup Analyses</title>
          <p>If appropriate, we will provide a narrative overview of subgroups, including different interventions, participants, and geographic regions.</p>
        </sec>
      </sec>
    </sec>
    <sec sec-type="results">
      <title>Results</title>
      <p>This project was funded by the Sir David Cooksey Fellowship in Healthcare Translation at the University of Oxford, Oxford, United Kingdom. We will submit the full systematic review for publication in the <italic>Journal of Medical Internet Research</italic>.</p>
    </sec>
    <sec sec-type="discussion">
      <title>Discussion</title>
      <p>We will systematically review the evidence on apps to facilitate the vaccination process. Our review will follow, where possible, the Cochrane Collaboration and the Centre for Review and Dissemination methodologies for conducting systematic reviews. We will report our findings based on guidelines from the PRISMA statement. A comprehensive search of the evidence will be conducted. A potential limitation of this review is that the quality and quantity of studies using similar methods and interventions may be limited. The review results will be used to inform the development of a vaccination app.</p>
    </sec>
  </body>
  <back>
    <app-group>
      <supplementary-material id="app1">
        <label>Multimedia Appendix 1</label>
        <p>Reporting checklist based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols (PRISMA-P) guidelines and draft searches.</p>
        <media xlink:href="resprot_v9i2e16929_app1.docx" xlink:title="DOCX File , 21 KB"/>
      </supplementary-material>
    </app-group>
    <glossary>
      <title>Abbreviations</title>
      <def-list>
        <def-item>
          <term id="abb1">AXIS</term>
          <def>
            <p>Appraisal tool for Cross-Sectional Studies</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb2">CASP</term>
          <def>
            <p>Critical Appraisal Skills Programme</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb3">CENTRAL</term>
          <def>
            <p>Cochrane Central Register of Controlled Trials</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb4">ERIC</term>
          <def>
            <p>Education Resources Information Center</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb5">HPV</term>
          <def>
            <p>human papillomavirus</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb6">JMIR</term>
          <def>
            <p>
              <italic>Journal of Medical Internet Research</italic>
            </p>
          </def>
        </def-item>
        <def-item>
          <term id="abb7">MMR</term>
          <def>
            <p>measles, mumps, and rubella</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb8">PRISMA</term>
          <def>
            <p>Preferred Reporting Items for Systematic Reviews and Meta-Analyses</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb9">PRISMA-P</term>
          <def>
            <p>Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb10">ROBINS-I</term>
          <def>
            <p>Risk Of Bias In Non-randomized Studies-of Interventions</p>
          </def>
        </def-item>
      </def-list>
    </glossary>
    <ack>
      <p>This work was funded by the Sir David Cooksey Fellowship in Healthcare Translation at the University of Oxford, Oxford, United Kingdom.</p>
    </ack>
    <fn-group>
      <fn fn-type="con">
        <p>MM and EM conceived the study topic. EM and CdC set initial search parameters. MHVV drafted the protocol. EM, MMI, CdC, and MM revised and edited the drafted manuscript.</p>
      </fn>
      <fn fn-type="conflict">
        <p>None declared.</p>
      </fn>
    </fn-group>
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