BACKGROUND: The increased pervasiveness of digital health technology is producing large amounts of person-generated health data (PGHD). These data can empower people to monitor their health to promote prevention and management of disease. Women make up one of the largest groups of consumers of digital self-tracking technology.
OBJECTIVE: In this scoping review, we aimed to (1) identify the different areas of women\'s health monitored using PGHD from connected health devices, (2) explore personal metrics collected through these technologies, and (3) synthesize facilitators of and barriers to women\'s adoption and use of connected health devices.
METHODS: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for scoping reviews, we searched 5 databases for articles published between January 1, 2015, and February 29, 2020. Papers were included if they targeted women or female individuals and incorporated digital health tools that collected PGHD outside a clinical setting.
RESULTS: We included a total of 406 papers in this review. Articles on the use of PGHD for women steadily increased from 2015 to 2020. The health areas that the articles focused on spanned several topics, with pregnancy and the postpartum period being the most prevalent followed by cancer. Types of digital health used to collect PGHD included mobile apps, wearables, websites, the Internet of Things or smart devices, 2-way messaging, interactive voice response, and implantable devices. A thematic analysis of 41.4% (168/406) of the papers revealed 6 themes regarding facilitators of and barriers to women\'s use of digital health technology for collecting PGHD: (1) accessibility and connectivity, (2) design and functionality, (3) accuracy and credibility, (4) audience and adoption, (5) impact on community and health service, and (6) impact on health and behavior.
CONCLUSIONS: Leading up to the COVID-19 pandemic, the adoption of digital health tools to address women\'s health concerns was on a steady rise. The prominence of tools related to pregnancy and the postpartum period reflects the strong focus on reproductive health in women\'s health research and highlights opportunities for digital technology development in other women\'s health topics. Digital health technology was most acceptable when it was relevant to the target audience, was seen as user-friendly, and considered women\'s personalization preferences while also ensuring accuracy of measurements and credibility of information. The integration of digital technologies into clinical care will continue to evolve, and factors such as liability and health care provider workload need to be considered. While acknowledging the diversity of individual needs, the use of PGHD can positively impact the self-care management of numerous women\'s health journeys. The COVID-19 pandemic has ushered in increased adoption and acceptance of digital health technology. This study could serve as a baseline comparison for how this field has evolved as a result.
UNASSIGNED: RR2-10.2196/26110.

Person-generated health data (PGHD) are valuable to study outcomes relevant to everyday living, to obtain information not otherwise available, for long-term follow-up and in situations where decisions cannot wait for traditional clinical research to be completed. While there is no dispute that these data are subject to bias, insights gained may be better than an information void, provided the biases are understood and acknowledged. People will share information known uniquely to them about exposures that may affect drug tolerance, safety and effectiveness, e.g., using non-prescription and complementary medications, alcohol, tobacco, illicit drugs, exercise, etc. Patients may be the best source of safety information when long-term follow-up is needed, e.g., the 5-15-year follow-up required for some gene therapies. Validation studies must be performed to evaluate what people can accurately report and when supplementary confirmation information is needed. But PGHD has already proven valuable in quantifying and contrasting COVID-19 vaccine benefits and risks, and for evaluating disease transmission and the accuracy of COVID-19 testing. Going forward, PGHD will be used for patient-measured and patient-relevant outcomes, including regulatory purposes, and will be linked to broader health data networks using tokenization, becoming a mainstay for signals about risks and benefits for diverse populations.

BACKGROUND: This exploratory study compares self-reported COVID-19 vaccine side effects and breakthrough infections in people who described themselves as having diabetes with those who did not identify as having diabetes.
OBJECTIVE: The study uses person-reported data to evaluate differences in the perception of COVID-19 vaccine side effects between adults with diabetes and those who did not report having diabetes.
METHODS: This is a retrospective cohort study conducted using data provided online by adults aged 18 years and older residing in the United States. The participants who voluntarily self-enrolled between March 19, 2021, and July 16, 2022, in the IQVIA COVID-19 Active Research Experience project reported clinical and demographic information, COVID-19 vaccination, whether they had experienced any side effects, test-confirmed infections, and consented to linkage with prescription claims. No distinction was made for this study to differentiate prediabetes or type 1 and type 2 diabetes nor to verify reports of positive COVID-19 tests. Person-reported medication use was validated using pharmacy claims and a subset of the linked data was used for a sensitivity analysis of medication effects. Multivariate logistic regression was used to estimate the adjusted odds ratios of vaccine side effects or breakthrough infections by diabetic status, adjusting for age, gender, education, race, ethnicity (Hispanic or Latino), BMI, smoker, receipt of an influenza vaccine, vaccine manufacturer, and all medical conditions. Evaluations of diabetes medication-specific vaccine side effects are illustrated graphically to support the examination of the magnitude of side effect differences for various medications and combinations of medications used to manage diabetes.
RESULTS: People with diabetes (n=724) reported experiencing fewer side effects within 2 weeks of vaccination for COVID-19 than those without diabetes (n=6417; mean 2.7, SD 2.0 vs mean 3.1, SD 2.0). The adjusted risk of having a specific side effect or any side effect was lower among those with diabetes, with significant reductions in fatigue and headache but no differences in breakthrough infections over participants\' maximum follow-up time. Diabetes medication use did not consistently affect the risk of specific side effects, either using self-reported medication use or using only diabetes medications that were confirmed by pharmacy health insurance claims for people who also reported having diabetes.
CONCLUSIONS: People with diabetes reported fewer vaccine side effects than participants not reporting having diabetes, with a similar risk of breakthrough infection.
BACKGROUND: ClinicalTrials.gov NCT04368065; https://clinicaltrials.gov/study/NCT04368065.

Despite the potential benefits of Person Generated Health Data (PGHD), data quality issues impede its use. This study examined the effect of different methods for filtering armband data on determining the amount of healthy walking and the consistency between healthy walking captured using armbands and health diaries. Four weeks of armband and health diary data were acquired from 103 college students. Armband data filtering was performed using heart rate measures and minimum daily step counts as a proxy for adequate daily wear time. No substantial differences in the filtered armband datasets were observed by filtering methods. Significant gaps were observed between healthy walking amounts determined from armband data and through the health diary. Future studies need to explore more diverse data filtering methods and their impact on health outcome assessments.

This study aimed to explore the adoption of person-generated health data in clinical settings and discern the factors influencing clinicians\' willingness to use it. A web-based survey containing 48 questions was developed based on prior research and the Unified Theory of Acceptance and Use of Technology 2 model. The survey was administered to a convenience sample of 486 nurses and physicians in South Korea recruited through an online community and snowball sampling. Of these, 70.7% were physicians. While 65% had used mobile health apps and devices, only 12.8% were familiar with person-generated health data. Still, a promising 73.3% expressed interest in incorporating person-generated health data into patient care, particularly data on blood glucose and vital signs. The findings of the study also indicated that clinicians specializing in internal medicine (OR: 1.9, CI: 1.16-3.19), familiar with person-generated health data (OR: 2.6, CI: 1.58-4.29), with a positive view of information and communication technology adoption (OR: 2.6, CI: 1.65-4.13), and who see the value in person-generated health data (OR: 3.9, CI: 2.55-6.09) showed higher inclination to utilize it. However, those in outpatient settings (OR: 0.4, CI: 0.19-0.73) showed less enthusiasm. The findings of this study suggest that despite the willingness of clinicians to use person-generated health data, various barriers must be addressed first, including a lack of knowledge regarding its use, concerns about data reliability and quality, and a lack of provider incentives. Overcoming these challenges demands concerted organizational or policy support. This research underscores person-generated health data\'s untapped potential in healthcare and the pressing need for strategies that facilitate its clinical integration.

The use of data from smartphones and wearable devices has huge potential for population health research, given the high level of device ownership; the range of novel health-relevant data types available from consumer devices; and the frequency and duration with which data are, or could be, collected. Yet, the uptake and success of large-scale mobile health research in the last decade have not met this intensely promoted opportunity. We make the argument that digital person-generated health data are required and necessary to answer many top priority research questions, using illustrative examples taken from the James Lind Alliance Priority Setting Partnerships. We then summarize the findings from 2 UK initiatives that considered the challenges and possible solutions for what needs to be done and how such solutions can be implemented to realize the future opportunities of digital person-generated health data for clinically important population health research. Examples of important areas that must be addressed to advance the field include digital inequality and possible selection bias; easy access for researchers to the appropriate data collection tools, including how best to harmonize data items; analysis methodologies for time series data; patient and public involvement and engagement methods for optimizing recruitment, retention, and public trust; and methods for providing research participants with greater control over their data. There is also a major opportunity, provided through the linkage of digital person-generated health data to routinely collected data, to support novel population health research, bringing together clinician-reported and patient-reported measures. We recognize that well-conducted studies need a wide range of diverse challenges to be skillfully addressed in unison (eg, challenges regarding epidemiology, data science and biostatistics, psychometrics, behavioral and social science, software engineering, user interface design, information governance, data management, and patient and public involvement and engagement). Consequently, progress would be accelerated by the establishment of a new interdisciplinary community where all relevant and necessary skills are brought together to allow for excellence throughout the life cycle of a research study. This will require a partnership of diverse people, methods, and technologies. If done right, the synergy of such a partnership has the potential to transform many millions of people\'s lives for the better.

Aim: It is important to assess if clinical trial efficacy translates into real-world effectiveness for COVID-19 vaccines. Materials & methods: We conducted a modified test-negative design (TND) to evaluate the real-world effectiveness of three COVID-19 vaccines. We defined cases in two ways: self-reported COVID-19-positive tests, and self-reported positive tests with ≥1 moderate/severe COVID-19 symptom. Results: Any vaccination was associated with a 95% reduction in subsequently reporting a positive COVID-19 test, and a 71% reduction in reporting a positive test and ≥1 moderate/severe symptom. Conclusion: We observed high effectiveness across all three marketed vaccines, both for self-reported positive COVID-19 tests and moderate/severe COVID-19 symptoms. This innovative TND approach can be implemented in future COVID-19 vaccine and treatment real-world effectiveness studies. Clinicaltrials.gov identifier: NCT04368065.

BACKGROUND: Dietary habits offer crucial information on one\'s health and form a considerable part of the patient-generated health data. Dietary data are collected through various channels and formats; thus, interoperability is a significant challenge to reusing this type of data. The vast scope of dietary concepts and the colloquial expression style add difficulty to standardizing the data. The interoperability issues of dietary data can be addressed through Common Data Elements with metadata annotation to some extent. However, making culture-specific dietary habits and questionnaire-based dietary assessment data interoperable still requires substantial efforts.
OBJECTIVE: The main goal of this study was to address the interoperability challenge of questionnaire-based dietary data from different cultural backgrounds by combining ontological curation and metadata annotation of dietary concepts. Specifically, this study aimed to develop a Dietary Lifestyle Ontology (DILON) and demonstrate the improved interoperability of questionnaire-based dietary data by annotating its main semantics with DILON.
METHODS: By analyzing 1158 dietary assessment data elements (367 in Korean and 791 in English), 515 dietary concepts were extracted and used to construct DILON. To demonstrate the utility of DILON in addressing the interoperability challenges of questionnaire-based multicultural dietary data, we developed 10 competency questions that asked to identify data elements sharing the same dietary topics and assessment properties. We instantiated 68 data elements on dietary habits selected from Korean and English questionnaires and annotated them with DILON to answer the competency questions. We translated the competency questions into Semantic Query-Enhanced Web Rule Language and reviewed the query results for accuracy.
RESULTS: DILON was built with 262 concept classes and validated with ontology validation tools. A small overlap (72 concepts) in the concepts extracted from the questionnaires in 2 languages indicates that we need to pay closer attention to representing culture-specific dietary concepts. The Semantic Query-Enhanced Web Rule Language queries reflecting the 10 competency questions yielded correct results.
CONCLUSIONS: Ensuring the interoperability of dietary lifestyle data is a demanding task due to its vast scope and variations in expression. This study demonstrated that we could improve the interoperability of dietary data generated in different cultural contexts and expressed in various styles by annotating their core semantics with DILON.

In 2017, an estimated 17.3 million adults in the United States experienced at least one major depressive episode, with 35% of them not receiving any treatment. Underdiagnosis of depression has been attributed to many reasons, including stigma surrounding mental health, limited access to medical care, and barriers due to cost.
This study aimed to determine if low-burden personal health solutions, leveraging person-generated health data (PGHD), could represent a possible way to increase engagement and improve outcomes.
Here, we present the development of PSYCHE-D (Prediction of Severity Change-Depression), a predictive model developed using PGHD from more than 4000 individuals, which forecasts the long-term increase in depression severity. PSYCHE-D uses a 2-phase approach. The first phase supplements self-reports with intermediate generated labels, and the second phase predicts changing status over a 3-month period, up to 2 months in advance. The 2 phases are implemented as a single pipeline in order to eliminate data leakage and ensure results are generalizable.
PSYCHE-D is composed of 2 Light Gradient Boosting Machine (LightGBM) algorithm-based classifiers that use a range of PGHD input features, including objective activity and sleep, self-reported changes in lifestyle and medication, and generated intermediate observations of depression status. The approach generalizes to previously unseen participants to detect an increase in depression severity over a 3-month interval, with a sensitivity of 55.4% and a specificity of 65.3%, nearly tripling sensitivity while maintaining specificity when compared with a random model.
These results demonstrate that low-burden PGHD can be the basis of accurate and timely warnings that an individual\'s mental health may be deteriorating. We hope this work will serve as a basis for improved engagement and treatment of individuals experiencing depression.

BACKGROUND: Due to their ability to collect person-generated health data, digital tools and connected health devices may hold great utility in disease prevention, chronic disease self-monitoring and self-tracking, as well as in tailoring information and educational content to fit individual needs. Facilitators and barriers to the use of digital health technologies vary across demographics, including sex. The \"femtech\" market is growing rapidly, and women are some of the largest adopters of digital health technologies.
OBJECTIVE: This paper aims to provide the background and methods for conducting a scoping review on the use of person-generated health data from connected devices in women\'s health. The objectives of the scoping review are to identify the various contexts of digital technologies in women\'s health and to consolidate women\'s views on the usability and acceptability of the devices.
METHODS: Searches were conducted in the following databases: Medline, Embase, APA PsycInfo, CINAHL Complete, and Web of Science Core Collection. We included articles from January 2015 to February 2020. Screening of articles was done independently by at least two authors in two stages. Data charting is being conducted in duplicate. Results will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist.
RESULTS: Our search identified 9102 articles after deduplication. As of November 2020, the full-text screening stage is almost complete and data charting is in progress. The scoping review is expected to be completed by Fall 2021.
CONCLUSIONS: This scoping review will broadly map the literature regarding the contexts and acceptability of digital health tools for women. The results from this review will be useful in guiding future digital health and women\'s health research.
UNASSIGNED: DERR1-10.2196/26110.