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This review is the result of a virtual, collaborative live review discussion organized and hosted by PREreview and JMIR Publications on June 4, 2026. The discussion was joined by 24 people: 3 facilitators from the PREreview Team, 3 members of the JMIR Publications team, and 18 live review participants. The authors of this review have dedicated additional asynchronous time over the course of two weeks to help compose this final report using the notes from the Live Review. We thank all participants who contributed to the discussion and made it possible for us to provide feedback on this preprint.

Summary:

Authors of this scoping review aimed to present the current state of the literature on wearable biosensors and patient-generated digital data in pediatric cardiology and congenital heart disease. The method involved a structured search on publicly accessible PubMed/MEDLINE, PubMed Central, and web-indexed searches on May 3, 2026 with PRISMA-ScR reporting principles. The search was focused on key items, including cardiology components, namely interstage/home monitoring, telemedicine-linked monitoring, telecardiology auscultation, smartwatch/mobile ECG rhythm evaluation, ECG interval validation, CIED remote monitoring, and advanced wearable biomarker validation. The findings revealed that wearable biosensors and patient-generated digital data are already being used across pediatric cardiology, but the degree of clinical integration varies substantially. Pediatric smartwatch and mobile ECG studies show promise for capturing intermittent arrhythmia and validating interval measurements, but they also demonstrate why consumer data require cautious triage and confirmation.

There are substantial methodological and reporting weaknesses that limit the transparency, reproducibility, and verifiability of this scoping review. Most importantly, the search strategy is too narrow, relying on a limited number of databases and excluding potentially relevant grey literature. This approach risks missing key evidence and weakens the validity of conclusions. Reporting falls short of standards, with missing or unusable PRISMA-ScR elements and inaccessible appendices, while FAIR-compliant data sharing is much needed. More solid quantitative reporting and clearer discussions of practical issues, such as caregiver burden, are also needed. In addition, the tables lack references, reducing clarity and verifiability. Including references in each section would improve usability. The review would also benefit from clearer definitions, inclusion of abbreviations, and stronger citations. Overall, the limited evidence base should be interpreted more cautiously and methodological gaps should be clearly and explicitly acknowledged to improve its reliability.

List of major concerns:

The topic is very interesting. Authors posted their work openly for feedback (preprint, a promotion of open science culture), followed ethics with disclosure of AI usage and have honestly mentioned some limitations in the discussion section. However, they need to give careful consideration to the nature and thoroughness of data to strengthen the results:

1. The manuscript is timely and has a great chance to be cited; however, its limited database coverage may have omitted relevant engineering or implementation studies, which would weaken the conclusions. The study would benefit from including freely accessible databases such as Google Scholar, Directory of Open Access Journals, ResearchGate, databases of non-peer-reviewed grey literature (dissertations/theses, scientific reports, conference abstracts), and Sciety or other open peer-reviewed preprint platforms (eLife, PREreview, Prelights, etc). Grey literature is essential in scoping reviews because the goal is to map all available evidence. It would be better if the authors provided their reasons for the exclusion of this type of literature search. Some large public or national libraries offer access to databases like Scopus/Web of Science. The language (English, French, etc.) and scientific documents should be considered for inclusion or exclusion criteria: original research articles, thesis, conference papers, book chapter, peer-reviewed reprints, scientific reports, etc. To be specific, authors could specify that they only focused on peer-reviewed original research articles from all accessible databases and peer-reviewed preprints from social platforms with English language (general language of science) focus for inclusion criteria.

2. In the Information Sources and Search Strategy section of the manuscript, it was mentioned that “Institutional access to Embase, Scopus/Web of Science, CINAHL, and IEEE Xplore was not available for this review”. It is not clear whether Institutional access to databases is available per article. Even though this limitation is explicitly addressed, the review may have missed some relevant studies, which would reduce the strength of the conclusions.

3. For data availability statement: share firstly Data (workbook) in a FAIR-compliant generalist repository (F-findable, A-accessible, I-interoperable, R-re-usable) (Dryad with 150$ for assistance with peer-reviewed for the first time and next time with the Dryad model/feedback use free Zenodo, OSF or fingshare) and then mention in this part the DOI (persistent link) to allow readers/community to get access. If you are not sure how to do it, I suggest you search for a data steward or data service librarian at your University’s Departments or consider training for open data (dataset sharing) with the promotion/new trend of open science (open research) of today for collaborative, inclusive, and reproducible research.

4. Reproducibility: the Multimedia Appendix links were blocked by the antivirus, and the PRISMA-ScR checklist was not available. For the PRISMA-ScR checklist, you can, for example, add it in an open format file (PDF/A or another) in a ZIP folder of your open data. In the Eligibility Criteria section, Language limits, Date limits, and Search end date were not mentioned, limiting the transparency and reproducibility of the study.

5. The tables were not cited in the text. Adding the table number to the relevant paragraph enhances the clarity of the results presentation and the readability of the article.

6. The references for the data presented in Tables 3, 4 & 5 should be mentioned.

7. The authors should incorporate any quantitative data into the reporting in the form of tables, graphs, etc. Though this is not a prerequisite for scoping reviews, it might improve the readability and clarity of the paper itself. Moreover, when papers broach different population groups, demographics, etc., readers are very much interested in p-values, alpha values, the distribution of data, quantitative analysis, and comparability testing (e.g., Fisher's test, ANOVA tests, whether the data is normalized or not).

8. The references for the twenty-two records that were included in the review should be mentioned. It is not clear which records are primary or clinically extractable sources, and which are retained as background or source-mining records. References should be clearly identified, documented, and cited; documenting and citing all included sources is a critical component of a high-quality scoping review

9. It is not clear what the phrase “strongest evidence” means within the context of the manuscript. Number of studies? Clinical validation? Implementation readiness? Consistency across sources? Readers need to know what benchmark is being used before they can take that characterization at face value. Kindly expand this phrase to improve the readability of the manuscript.

10. There is some inconsistency in the single ventricle and high-risk CHD home monitoring section. The authors mentioned one specific app by name, but then no others. The rest of the section categorized differences in terms of function. I would love to know the names of any other apps because, for practitioners, it’s helpful to know about new things. But if only one is going to be identified, then I think it would be better not to focus on it.

11. The authors have done a scoping review of a medical issue that is high-risk, no matter what. A lot of pediatric cardiology patients are too young or too unwell to manage monitoring technology themselves, which means caregivers carry real weight here. Where it concerns pre-verbal people who are cared for by home caregivers, there is some mention of economics, but I should think that for implementation gaps or recommendations, there is a glaring gap if there is nothing about the importance/cost/time involved/responsibility for effectively training the caregivers in terms of how to use any of the home-based technology. Is there anything out there already that deals with this? I think the authors should feel free to make suggestions like these.

12. The limited evidence base should be handled more carefully in the interpretation. The review draws on a relatively small number of sources, most of them freely accessible, and the conclusions should reflect that. The authors should be upfront about what this means for completeness and generalizability rather than presenting findings with more confidence than the evidence supports.

13. The expected PRISMA-ScR reporting materials are missing. A completed PRISMA-ScR checklist and a flow diagram showing how records moved through the review process are standard expectations for this type of review. These should be included, along with a screening log or extraction workbook if possible.

List of minor concerns

• Tables lack clarity and verifiability (e.g., missing references within evidence clusters in Table 3). A helpful resource for readers would be the inclusion of the references in the tables, specifically in each section of the tables

• The manuscript would benefit from an abbreviation section. Some abbreviations appear without being introduced first. A consistent approach, defining each abbreviation at first use throughout the paper, would help readers follow along. In Table 1, please identify the abbreviation CIEDs as Cardiac Implantable Electronic Devices. In the Single-Ventricle and High-Risk Congenital Heart Disease Home Monitoring section, first paragraph: please identify the abbreviation AHA as the American Heart Association. Please spell out Cardiac High Acuity Monitoring Program (CHAMP) when initially introduced.

• The Discussion section could use a cleaner opening. The transition into the discussion feels a little abrupt. A brief orienting sentence or two that situates the findings before diving into detail would help readers get their bearings.

• Though the authors have disclosed the use of AI in writing this review, the manner in which it was used, the extent to which it was used, and the review of the generated text (as well as the prompts they input into whichever large-language model they used) should be disclosed to the audience

• In the references list, reference [24] lacks an issue number; reference [27] lacks DOI. Remove PMIC. Pubmed also provides DOI in the citation. So, copy and add DOI to the reference [27] to make your references have the same components. It's worth a careful pass through the reference list before resubmission.

• The age range for "young adult" should be defined. This term appears in the manuscript but without a clear boundary. Given that pediatric and adult care transitions matter in this clinical area, the authors should specify what they mean.

• The manuscript would benefit from a final grammar and clarity edit. There are scattered passages where the writing is harder to follow than it needs to be. A focused editing pass would improve readability throughout.

• The inclusion of certain targeted search phrases appears to correspond directly to the titles of studies cited in the review, suggesting a form of reverse searching for previously identified literature rather than an independent and systematic search strategy.

• It would be good to add whether the protocol was registered or publicly posted, and perhaps make a better case of why the search was limited, and acknowledge the limitation around this.

• References to specific apps and tools should be handled more consistently. Some are named and described in detail, others are mentioned only briefly. The level of treatment should be more even across the manuscript.

• The conclusion should land more strongly. The practical takeaway from this review, what clinicians, implementers, or policymakers should actually do with these findings, should be stated more clearly and confidently in the conclusion.

• The ethics statement should be explicit about approval not being required. Simply stating that no patient data was used isn't quite enough. The authors should state directly that ethics approval was not required for this type of review, and ideally, note why.

• It is unclear whether pediatric heart transplant recipients were included within the scope of the review. Please clarify the inclusion/exclusion criteria regarding transplant patients, as this may represent an important subgroup in pediatric cardiology.

• Terminology for cardiac implantable electronic devices is inconsistent throughout the manuscript. Both the full term (cardiac implantable electronic device) and the abbreviation (CIED) are used in different sections. Consider standardizing usage and defining the abbreviation at first mention. Similarly, both electrocardiography and ECG are used throughout the manuscript. For consistency and readability, define the abbreviation at first use and use a uniform term thereafter.

Concluding remarks

We thank the authors of the preprint for posting their work openly for feedback. We also thank all participants of the Live Review call for their time and for engaging in the lively discussion that generated this review.

Competing interests

The authors declare that they have no competing interests.

Use of Artificial Intelligence (AI)

The authors declare that they did not use generative AI to come up with new ideas for their review.