<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD Journal Publishing DTD v2.0 20040830//EN" "journalpublishing.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" dtd-version="2.0" xml:lang="en" article-type="letter"><front><journal-meta><journal-id journal-id-type="nlm-ta">JMIR Mhealth Uhealth</journal-id><journal-id journal-id-type="publisher-id">mhealth</journal-id><journal-id journal-id-type="index">13</journal-id><journal-title>JMIR mHealth and uHealth</journal-title><abbrev-journal-title>JMIR Mhealth Uhealth</abbrev-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">v13i1e85329</article-id><article-id pub-id-type="doi">10.2196/85329</article-id><article-categories><subj-group subj-group-type="heading"><subject>Letter to the Editor</subject></subj-group></article-categories><title-group><article-title>Methodological Considerations in Evaluating Mental Health Apps: Ensuring Reliability and Patient Safety</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name name-style="western"><surname>Balakrishna</surname><given-names>Harikrishnan</given-names></name><degrees>MBBS, MBA</degrees><xref ref-type="aff" rid="aff1"/></contrib></contrib-group><aff id="aff1"><institution>Department of Health Services, Family Health Centre, Kilikolloor</institution><addr-line>Government of Kerala, Mangadu PO</addr-line><addr-line>Kollam</addr-line><country>India</country></aff><contrib-group><contrib contrib-type="editor"><name name-style="western"><surname>Brini</surname><given-names>Stefano</given-names></name></contrib></contrib-group><author-notes><corresp>Correspondence to Harikrishnan Balakrishna, MBBS, MBA, Department of Health Services, Family Health Centre, Kilikolloor, Government of Kerala, Mangadu PO, Kollam, 691015, India, 91 8078379594; <email>drhari.793594@kerala.gov.in</email></corresp></author-notes><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>19</day><month>11</month><year>2025</year></pub-date><volume>13</volume><elocation-id>e85329</elocation-id><history><date date-type="received"><day>05</day><month>10</month><year>2025</year></date><date date-type="rev-recd"><day>18</day><month>10</month><year>2025</year></date><date date-type="accepted"><day>19</day><month>10</month><year>2025</year></date></history><copyright-statement>&#x00A9; Harikrishnan Balakrishna. Originally published in JMIR mHealth and uHealth (<ext-link ext-link-type="uri" xlink:href="https://mhealth.jmir.org">https://mhealth.jmir.org</ext-link>), 19.11.2025. </copyright-statement><copyright-year>2025</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 (<ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">https://creativecommons.org/licenses/by/4.0/</ext-link>), 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 <ext-link ext-link-type="uri" xlink:href="https://mhealth.jmir.org/">https://mhealth.jmir.org/</ext-link>, as well as this copyright and license information must be included.</p></license><self-uri xlink:type="simple" xlink:href="https://mhealth.jmir.org/2025/1/e85329"/><related-article related-article-type="commentary article" ext-link-type="doi" xlink:href="10.2196/79238" xlink:title="Comment on" xlink:type="simple">https://mhealth.jmir.org/2025/1/e79238</related-article><related-article related-article-type="commentary" ext-link-type="doi" xlink:href="10.2196/85910" xlink:title="Comment in" xlink:type="simple">https://mhealth.jmir.org/2025/1/e85910</related-article><kwd-group><kwd>mental health apps</kwd><kwd>mHealth</kwd><kwd>review of apps</kwd><kwd>smartphone apps</kwd><kwd>MHApps for Indian users</kwd><kwd>India</kwd><kwd>mobile phones</kwd></kwd-group></article-meta></front><body><p>We read with great interest and appreciate Mehrotra et al [<xref ref-type="bibr" rid="ref1">1</xref>] for their systematic review of mental health apps accessible to Indian users. Their assessment of 350 apps provides valuable insight into the current digital mental health landscape in India. Still, several methodological and reporting considerations require clarification. This letter addresses 3 key areas: interrater reliability, sampling scope, and patient safety considerations.</p><p>To establish interrater reliability, the Mobile Application Rating Scale (MARS) was developed and validated with independent dual ratings and calculation of intraclass correlation coefficients (ICCs) [<xref ref-type="bibr" rid="ref2">2</xref>]. Mehrotra et al [<xref ref-type="bibr" rid="ref1">1</xref>] describe efforts like joint training and expert validation of a small subsample but divide the remaining apps among 4 reviewers for independent evaluation. ICC values for the main ratings were not reported, an approach that deviates from the established MARS methodology [<xref ref-type="bibr" rid="ref2">2</xref>]. A past study demonstrated that when MARS is applied without strict dual-rater methodology, interrater agreement can be low (Krippendorff &#x03B1;=0.29), indicating high variability among reviewers [<xref ref-type="bibr" rid="ref3">3</xref>]. Without ICC data, it is difficult to determine whether differences in app quality scores reflect their true variation or rater inconsistency. Reporting ICCs for a random subsample or acknowledging this limitation would improve interpretability for clinical application.</p><p>Regarding sampling scope, World Health Organization (WHO) guidance emphasizes transparent reporting and clear description of inclusion criteria for digital health interventions to support accurate interpretation and generalizability [<xref ref-type="bibr" rid="ref4">4</xref>]. The study assessed only free apps and freely accessible portions of paid apps, yet its conclusions are framed as applying to all &#x201C;mental health apps available to Indian users.&#x201D; Premium apps often differ from free ones in professional input, empirical validation, and privacy safeguards. The finding that 65% of apps lacked professional input and only 11% cited empirical research [<xref ref-type="bibr" rid="ref1">1</xref>] may therefore not represent the entire app ecosystem. This approach limits its generalizability and could mislead policymakers and clinicians relying on evidence-based recommendations. Hence, conclusions should be categorically limited to the free or freemium app marketplace or, in future work, expanded to include paid apps.</p><p>Regarding patient safety considerations, WHO guidance emphasizes that systematic evaluations of digital health interventions should transparently identify and report potential harms to support safe implementation and evidence-based decision-making [<xref ref-type="bibr" rid="ref4">4</xref>]. The authors identified apps with potentially harmful features, such as misleading claims or alarming feedback without crisis support, but did not indicate whether these concerns were addressed or reported in any way. Vulnerable patients experiencing mental health crises could have worsened outcomes when exposed to such inadequately designed assessment tools [<xref ref-type="bibr" rid="ref5">5</xref>]. Empirical evidence shows that adverse events in consumer-facing mental health apps are underreported and may pose significant risks to users [<xref ref-type="bibr" rid="ref5">5</xref>]. Highlighting such risks ensures that clinicians, policymakers, and end users are aware of potential harms when translating review findings into practice, without implying that reviewers are responsible for regulatory action.</p><p>Clarifying interrater reliability, explicitly defining app sampling scope, and transparently reporting safety-relevant issues strengthen the interpretability and applicability of systematic reviews in digital mental health. Methodological limitations, such as inconsistent rating procedures or selective sampling, reduce confidence in app quality scores and limit generalizability. While patient safety considerations are primarily reporting issues, systematically highlighting potentially harmful apps enhances the practical utility of reviews and supports safe evidence-based decisions.</p></body><back><ack><p>Minor language refinement and reference formatting were assisted by ChatGPT (GPT-5; OpenAI). All factual content, data, and interpretations were authored, verified, and approved entirely by the author.</p></ack><fn-group><fn fn-type="conflict"><p>None declared.</p></fn></fn-group><glossary><title>Abbreviations</title><def-list><def-item><term id="abb1">ICC</term><def><p>intraclass correlation coefficient</p></def></def-item><def-item><term id="abb2">MARS</term><def><p>Mobile Application Rating Scale</p></def></def-item><def-item><term id="abb3">WHO</term><def><p>World Health Organization</p></def></def-item></def-list></glossary><ref-list><title>References</title><ref id="ref1"><label>1</label><nlm-citation citation-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Mehrotra</surname><given-names>S</given-names> </name><name name-style="western"><surname>Tripathi</surname><given-names>R</given-names> </name><name name-style="western"><surname>Sengupta</surname><given-names>P</given-names> </name><etal/></person-group><article-title>Evaluating characteristics and quality of mental health apps available in app stores for Indian users: systematic app search and review</article-title><source>JMIR Mhealth Uhealth</source><year>2025</year><month>09</month><day>26</day><volume>13</volume><fpage>e79238</fpage><pub-id pub-id-type="doi">10.2196/79238</pub-id><pub-id pub-id-type="medline">41004798</pub-id></nlm-citation></ref><ref id="ref2"><label>2</label><nlm-citation citation-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Stoyanov</surname><given-names>SR</given-names> </name><name name-style="western"><surname>Hides</surname><given-names>L</given-names> </name><name name-style="western"><surname>Kavanagh</surname><given-names>DJ</given-names> </name><name name-style="western"><surname>Zelenko</surname><given-names>O</given-names> </name><name name-style="western"><surname>Tjondronegoro</surname><given-names>D</given-names> </name><name name-style="western"><surname>Mani</surname><given-names>M</given-names> </name></person-group><article-title>Mobile App Rating Scale: a new tool for assessing the quality of health mobile apps</article-title><source>JMIR Mhealth Uhealth</source><year>2015</year><month>03</month><day>11</day><volume>3</volume><issue>1</issue><fpage>e27</fpage><pub-id pub-id-type="doi">10.2196/mhealth.3422</pub-id><pub-id pub-id-type="medline">25760773</pub-id></nlm-citation></ref><ref id="ref3"><label>3</label><nlm-citation citation-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Mir&#x00F3;</surname><given-names>J</given-names> </name><name name-style="western"><surname>Llorens-Vernet</surname><given-names>P</given-names> </name></person-group><article-title>Assessing the quality of mobile health-related apps: interrater reliability study of two guides</article-title><source>JMIR Mhealth Uhealth</source><year>2021</year><month>04</month><day>19</day><volume>9</volume><issue>4</issue><fpage>e26471</fpage><pub-id pub-id-type="doi">10.2196/26471</pub-id><pub-id pub-id-type="medline">33871376</pub-id></nlm-citation></ref><ref id="ref4"><label>4</label><nlm-citation citation-type="book"><source>Recommendations on Digital Interventions for Health System Strengthening</source><year>2019</year><access-date>2025-11-05</access-date><publisher-name>World Health Organization</publisher-name><comment><ext-link ext-link-type="uri" xlink:href="https://www.ncbi.nlm.nih.gov/books/NBK541905/">https://www.ncbi.nlm.nih.gov/books/NBK541905/</ext-link></comment></nlm-citation></ref><ref id="ref5"><label>5</label><nlm-citation citation-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Taher</surname><given-names>R</given-names> </name><name name-style="western"><surname>Hsu</surname><given-names>CW</given-names> </name><name name-style="western"><surname>Hampshire</surname><given-names>C</given-names> </name><etal/></person-group><article-title>The safety of digital mental health interventions: systematic review and recommendations</article-title><source>JMIR Ment Health</source><year>2023</year><month>10</month><day>9</day><volume>10</volume><fpage>e47433</fpage><pub-id pub-id-type="doi">10.2196/47433</pub-id><pub-id pub-id-type="medline">37812471</pub-id></nlm-citation></ref></ref-list></back></article>