Designing mHealth Apps to Incorporate Evidence-Based Techniques for Prolonging User Engagement.

Maintaining user engagement with mobile health (mHealth) apps can be a challenge. Previously, we developed a conceptual model to optimize patient engagement in mHealth apps by incorporating multiple evidence-based methods, including increasing health literacy, enhancing technical competence, and improving feelings about participation in clinical trials. This viewpoint aims to report on a series of exploratory mini-experiments demonstrating the feasibility of testing our previously published engagement conceptual model. We collected data from 6 participants using an app that showed a series of educational videos and obtained additional data via questionnaires to illustrate and pilot the approach. The videos addressed 3 elements shown to relate to engagement in health care app use: increasing health literacy, enhancing technical competence, and improving positive feelings about participation in clinical trials. We measured changes in participants' knowledge and feelings, collected feedback on the videos and content, made revisions based on this feedback, and conducted participant reassessments. The findings support the feasibility of an iterative approach to creating and refining engagement enhancements in mHealth apps. Systematically identifying the key evidence-based elements intended to be included in an app's design and then systematically testing the implantation of each element separately until a satisfactory level of positive impact is achieved is feasible and should be incorporated into standard app design. While mHealth apps have shown promise, participants are more likely to drop out than to be retained. This viewpoint highlights the potential for mHealth researchers to test and refine mHealth apps using approaches to better engage users.

Mobile app activity engagement by cancer patients and their caregivers informs remote monitoring.

Mobile phone applications ("apps") are potentially an effective, low-burden method to collect patient-reported outcomes outside the clinical setting. Using such apps consistently and in a timely way is critical for complete and accurate data capture, but no studies of concurrent reporting by cancer patient-caregiver dyads have been published in the peer-reviewed literature. This study assessed app engagement, defined as adherence, timing, and attrition with two smartphone applications, one for adult cancer patients and one for their informal caregivers. This was a single-arm, pilot study in which adult cancer patients undergoing IV chemotherapy or immunotherapy used the DigiBioMarC app, and their caregivers used the TOGETHERCare app, for approximately one month to report weekly on the patients' symptoms and wellbeing. Using app timestamp metadata, we assessed user adherence, overall and by participant characteristics. Fifty patient-caregiver dyads completed the study. Within the one-month study period, both adult cancer patients and their informal caregivers were highly adherent, with app activity completion at 86% for cancer patients and 84% for caregivers. Caregivers completed 86% of symptom reports, while cancer patients completed 89% of symptom reports. Cancer patients and their caregivers completed most activities within 48 h of availability on the app. These results suggest that the DigiBioMarC and TOGETHERCare apps can be used to collect patient- and caregiver-reported outcomes data during intensive treatment. From our research, we conclude that metadata from mobile apps can be used to inform clinical teams about study participants' engagement and wellbeing outside the clinical setting.

Correction: Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study.

[This corrects the article DOI: 10.2196/49100.].

Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study.

BACKGROUND: Timely collection of patient-reported outcomes (PROs) decreases emergency department visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers' reporting using similar clinical outcome assessments. OBJECTIVE: The aim of this study is to assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs) and if PROs were associated with future clinical events. METHODS: We developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients' electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events. RESULTS: Participants completed 97% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients' hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (P<.05), and hospice referrals (P=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (P=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (P=.03), while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks. CONCLUSIONS: In this study, caregivers and patients completed PROs using smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity.

Usability evaluation of mobile phone technologies for capturing cancer patient-reported outcomes and physical functions.

Background: By eliminating the requirement for participants to make frequent visits to research sites, mobile phone applications ("apps") may help to decentralize clinical trials. Apps may also be an effective mechanism for capturing patient-reported outcomes and other endpoints, helping to optimize patient care during and outside of clinical trials. Objectives: We report on the usability of Digital BioMarkers for Clinical Impact (DigiBioMarC™ (DBM)), a novel smartphone-based app used by cancer patients in conjunction with a wearable device (Apple Watch®). DBM is designed to collect patient-reported outcomes and record physical functions. Methods: In a fully decentralized "bring-your-own-device" smartphone study, we enrolled 54 cancer patient and caregiver dyads from Kaiser Permanente Northern California (KPNC) from October 2020 through March 2021. Patients used the app for at least 28 days, completed weekly questionnaires about their symptoms, physical functions, and mood, and performed timed physical tasks. Usability was determined through a subset of the Mobile App Rating Scale (MARS), the full System Usability Scale (SUS), the Net Promoter Score (NPS), and semi-structured interviews. Results: We obtained usability survey data from 50 of 54 patients. Median responses to the selected MARS questions and the mean SUS scores indicated above average usability. The NPS from the semi-structured interviews at the end of the study was 24, indicating a favorable score. Conclusions: Cancer patients reported above average usability for the DBM app. Qualitative analyses indicated that the app was easy to use and helpful. Future work will emphasize implementing further patient recommendations and evaluating the app's clinical efficacy in multiple settings.

A novel smartphone application for the informal caregivers of cancer patients: Usability study.

Informal caregivers are a critical source of support for cancer patients. However, their perspectives are not routinely collected, despite health impacts related to the burden of caregiving. We created the TOGETHERCare smartphone application (app) to collect observer-reported outcomes regarding the cancer patient's health and caregiver's perceptions of their own mental and physical health, and to provide tips and resources for self-care and patient care. We enrolled 54 caregivers between October 2020 and March 2021 from Kaiser Permanente Northern California (KPNC), an integrated healthcare system. Fifty caregivers used the app for approximately 28 days. Usability and acceptability were assessed using questions from the Mobile App Rating Scale (MARS), the System Usability Scale (SUS), the Net Promoter Score (NPS), and semi-structured interviews. The caregivers' mean age was 54.4 years, 38% were female and 36% were non-White. The SUS total mean score was 83.4 (SD = 14.2), for a percentile rank of 90-95 ("excellent"). Median MARS responses to the functionality questions were also high. The NPS score of 30 at the end of the study indicated that most caregivers would recommend the app. Themes from semi-structured interviews were consistent across the study period and indicated that the app was easy to use and helpful. Caregivers indicated a need for feedback from the app, suggested some changes to the wording of questions, the app's visuals, and timing of notifications. This study demonstrated that caregivers are willing to complete frequent surveys about themselves and their patients. The app is unique because it provides a remote method to collect caregivers' observations about the patient that may be useful for clinical care. To our knowledge, TOGETHERCare is the first mobile app developed specifically to capture adult cancer patient symptoms from the informal caregiver's perspective. Future research will examine whether use of this app can help improve patient outcomes.

Assessing the Financial Value of Decentralized Clinical Trials.

BACKGROUND: Deployment of remote and virtual clinical trial methods and technologies, referred to collectively as decentralized clinical trials (DCTs), represents a profound shift in clinical trial practice. To our knowledge, a comprehensive assessment of the financial net benefits of DCTs has not been conducted. METHODS: We developed an expected net present value (eNPV) model of the cash flows for new drug development and commercialization to assess the financial impact of DCTs. The measure of DCT value is the increment in eNPV that occurs, on average, when DCT methods are employed in comparison to when they are not. The model is populated with parameter values taken from published studies, Tufts CSDD benchmark data, and Medable Inc. data on DCT projects. We also calculated the return on investment (ROI) in DCTs as the ratio of the increment in eNPV to the DCT implementation cost. RESULTS: We found substantial value from employing DCT methods in phase II and phase III trials. If we assume that DCT methods are applied to both phase II and phase III trials the increase in value is $20 million per drug that enters phase II, with a seven-fold ROI. CONCLUSIONS: DCTs can provide substantial extra value to sponsors developing new drugs, with high returns to investment in these technologies. Future research on this topic should focus on expanding the data to larger datasets and on additional aspects of clinical trial operations not currently measured.

A New Approach to Enhancing Engagement in eHealth Apps.

This viewpoint presents a 3-phase conceptual model of the process of user engagement with eHealth apps. We also describe how knowledge gleaned from psychosocial, behavioral, and cognitive science can be incorporated into this model to enhance user engagement with an eHealth app in each phase of the engagement process.

Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims : Let's Share the Success Stories to Move the Industry Forward.

Bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data in clinical trials can decrease patient burden and improve data quality. However, adoption of BYOD in clinical trials is limited by the absence of publicly available case studies where BYOD PRO data supported regulatory medical product approvals. Anecdotally, we are aware of multiple examples where efficacy and safety label claims were based on BYOD PRO data; however-except for one-these examples have not been made public. The absence of these case studies can lead sponsors to be hesitant to use BYOD for capturing primary and secondary PRO-based endpoints in their trials. This commentary outlines the context of the issue faced and concludes with a call for sponsor transparency with regard to BYOD use through publicizing where approved labeling claims were based on BYOD data. We suggest how this data could be systematically captured going forward. Sharing this information will benefit the clinical trials enterprise by increasing confidence in the utilization of BYOD and provide opportunities to enhance patient-centricity.

Evaluating the Impact of Social and Built Environments on Health-Related Quality of Life among Cancer Survivors.

BACKGROUND: With almost 17 million U.S. cancer survivors, understanding multilevel factors impacting health-related quality of life (HRQOL) is critical to improving survivorship outcomes. Few studies have evaluated neighborhood impact on HRQOL among cancer survivors. METHODS: We combined sociodemographic, clinical, and behavioral data from three registry-based studies in California. Using a three-level mixed linear regression model (participants nested within block groups and study/regions), we examined associations of both independent neighborhood attributes and neighborhood archetypes, which capture interactions inherent among neighborhood attributes, with two HRQOL outcomes, physical (PCS) and mental (MCS) composite scores. RESULTS: For the 2,477 survivors, 46% were 70+ years, 52% were non-Hispanic White, and 53% had localized disease. In models minimally adjusted for age, stage, and cancer recurrence, HRQOL was associated with neighborhood socioeconomic status (nSES), racial/ethnic composition, population density, street connectivity, restaurant environment index, traffic density, urbanicity, crowding, rental properties, and non-single family units. In fully adjusted models, higher nSES remained associated with better PCS, and restaurant environment index, specifically more unhealthy restaurants, associated with worse MCS. In multivariable-adjusted models of neighborhood archetype, compared with upper middle-class suburb, Hispanic small town and inner city had lower PCS, and high status had higher MCS. CONCLUSIONS: Among survivors, higher nSES was associated with better HRQOL; more unhealthy restaurants were associated with worse HQROL. As some neighborhood archetypes were associated with HRQOL, they provide an approach to capture how neighborhood attributes interact to impact HRQOL. IMPACT: Elucidating the pathways through which neighborhood attributes influence HRQOL is important in improving survivorship outcomes.

What Works Best to Engage Participants in Mobile App Interventions and e-Health: A Scoping Review.

Background: Despite the growing popularity of mobile app interventions, specific engagement components of mobile apps have not been well studied. Methods: The objectives of this scoping review are to determine which components of mobile health intervention apps encouraged or hindered engagement, and examine how studies measured engagement. Results: A PubMed search on March 5, 2020 yielded 239 articles that featured the terms engagement, mobile app/mobile health, and adult. After applying exclusion criteria, only 54 studies were included in the final analysis. Discussion: Common app components associated with increased engagement included: personalized content/feedback, data visualization, reminders/push notifications, educational information/material, logging/self-monitoring functions, and goal-setting features. On the other hand, social media integration, social forums, poor app navigation, and technical difficulties appeared to contribute to lower engagement rates or decreased usage. Notably, the review revealed a great variability in how engagement with mobile health apps is measured due to lack of established processes. Conclusion: There is a critical need for controlled studies to provide guidelines and standards to help facilitate engagement and its measurement in research and clinical trial work using mobile health intervention apps.

"Mother's Health and Well-Being Matters: Is a Mediated Social Cohesion Public Health Intervention Feasible?"

PURPOSE: To test the feasibility of introducing 'Free Time for Wellness' (FT4W) an intervention to increase healthy behaviours and reduce the risk of cancer. DESIGN: Feasibility study; Setting: Washington Heights, New York, USA is a low socioeconomic status area. SUBJECTS: Mothers aged 18 and above with children under 12 years of age and living in Washington Heights were recruited. INTERVENTION: FT4W, a community-based intervention delivered through a neighbourhood-based app, offering weekly dance and yoga classes, food pantry visits and group playdates. Childcare professionals cared for participants' children during wellness activities. MEASURES: A bespoke before and after survey was designed and tested for its ability to collect relevant data to assess the impact of FT4W. Outcomes included recruitment rates, participation, attrition, acceptability, and success of the community champion. ANALYSIS: Comparisons of proportions and means. RESULTS: Twenty-one mothers participated in the study of which 90% attended ≥ 1 FT4W activity; 65% ≥ 2; 52% ≥ 3. The survey was completed by a 100% of participants indicating it was easy to understand and not too burdensome. All measures detected change in constructs from baseline to follow-up. Availability of childcare was the most commonly (66%) reported reason participants were able to engage in the offered wellness activities. CONCLUSION: Conducting a larger-scale trial to assess the impact of FT4W is feasible considering 4 major lessons. (1) Recruitment, retention, and acceptability rates were high; however, moms need additional support to increase participation in wellness activities and improve tech literacy. (2) Research measures were sensitive enough to detect change, but the timing of assessments needs to be considered. (3) Participants greatly valued access to professional childcare. (4) The Community Champion is a necessary, but difficult role to fill that requires careful consideration by the Institutional Review Board (IRB).

Sensor Data Integration: A New Cross-Industry Collaboration to Articulate Value, Define Needs, and Advance a Framework for Best Practices.

Data integration, the processes by which data are aggregated, combined, and made available for use, has been key to the development and growth of many technological solutions. In health care, we are experiencing a revolution in the use of sensors to collect data on patient behaviors and experiences. Yet, the potential of this data to transform health outcomes is being held back. Deficits in standards, lexicons, data rights, permissioning, and security have been well documented, less so the cultural adoption of sensor data integration as a priority for large-scale deployment and impact on patient lives. The use and reuse of trustworthy data to make better and faster decisions across drug development and care delivery will require an understanding of all stakeholder needs and best practices to ensure these needs are met. The Digital Medicine Society is launching a new multistakeholder Sensor Data Integration Tour of Duty to address these challenges and more, providing a clear direction on how sensor data can fulfill its potential to enhance patient lives.

Free Time For Wellness: a co-designed intervention utilizing social networks to encourage physical activity for cancer prevention among low resourced mothers.

BACKGROUND: Physical activity is central to chronic disease prevention. Low resource mothers face structural barriers preventing them from increasing their physical activity to reduce their chronic disease risk. We co-designed an intervention, with the ultimate goal of building social cohesion through social media to increase physical activity for low resourced mothers in urban settings. METHODS: In 2019, we interviewed 10 mothers of children (< 12 years) living in Washington Heights, Manhattan. The interviews were transcribed and coded for themes that guided the creation of a co-design workshop. Washington Heights-based mothers (n = 16) attended a co-design workshop to generate the blueprint for the Free Time for Wellness intervention. RESULTS: Mothers in our sample had limited time, external support and resources, which hindered them from increasing their physical activity; we learned that in addition to physical health, mental health was a concern for participants. Participants had varying degrees of self-efficacy and trust in social media. Bringing mothers and researchers together in a co-design workshop, we identified types of physical activities they would enjoy participating in, the ideal time to do so, the kind of childcare they needed, and their preferences for communication with the community champion. The interviews and workshop highlighted the need for a community space that mothers and children could co-occupy. The intervention was designed to be 3 months' worth of sample programming with one activity per week, rotating between dance, yoga, food pantry visits and group playdates. Participants were invited to bring their children to a space with one room for the 'participants only' activity and a second room in which professional childcare providers supervised the children. CONCLUSIONS: Through this two-phased co-design process, we created an intervention with mothers in an urban community with the goal of using social media to bring them together for wellness, primarily through increased physical activity. Despite the co-design of this intervention with a specific community, there are some universal applications of our findings, and of the use of co-design workshops, to other settings.

Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial.

BACKGROUND: Breast cancer survivors often have persisting headache. In a secondary analysis of the Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) clinical trial (ClinicalTrials.gov identifier NCT02165839), the authors examined the effects of BBT-CI on headache outcomes in patients with breast cancer. METHODS: Patients with breast cancer who were receiving chemotherapy were randomly assigned to receive either the BBT-CI intervention or the Healthy EAting Education Learning for healthy sleep (HEAL) control intervention, and both were delivered over 6 weeks by trained staff. Headache outcomes and heart rate variability (HRV) were measured at baseline, 6 weeks, 6 months, and 12 months. Mixed-effects models were used to examine longitudinal headache outcomes in the groups according to the intention to treat. Principal component analysis and agglomerative hierarchical clustering were conducted to reduce 16 variables for data-driven phenotyping. RESULTS: Patients in the BBT-CI arm (n = 73) exhibited a significant reduction in headache burden over time (P = .02; effect size [Cohen d] = 0.43), whereas the reduction was not significant among those in the HEAL arm (n = 66). The first principal component was positively loaded by headache, sleep, fatigue, and nausea/vomiting and was negatively loaded by cognitive, physical, and emotional functioning. Agglomerative hierarchical clustering revealed 3 natural clusters. Cluster I (n = 58) featured the highest burden of headache, insomnia, and nausea/vomiting; cluster II (n = 50) featured the lowest HRV despite a low burden of headache and insomnia; and cluster III (n = 31) showed an inverse relation between HRV and headache-insomnia, signifying autonomic dysfunction. CONCLUSIONS: BBT-CI is efficacious in reducing headache burden in breast cancer survivors. Patient phenotyping demonstrates a headache type featuring sleep disturbance, nausea/vomiting, and low physical functioning-revealing similarities to migraine. LAY SUMMARY: Breast cancer survivors often have persisting headache symptoms. In patients with cancer, treatment of chronic headache disorders using daily medications may be challenging because of drug interactions with chemotherapy and other cancer therapies as well as patients' reluctance to add more drugs to their medicine list. Headache and sleep disorders are closely related to each other. This study demonstrates that a sleep behavioral therapy reduced headache burden in breast cancer survivors. In addition, the majority of headache sufferers had a headache type with similarities to migraine-featuring sleep disturbance, nausea/vomiting, and low physical functioning.

Development of a Mobile Health App (TOGETHERCare) to Reduce Cancer Care Partner Burden: Product Design Study.

BACKGROUND: Approximately 6.1 million adults in the United States serve as care partners for cancer survivors. Studies have demonstrated that engaging cancer survivors and their care partners through technology-enabled structured symptom collection has several benefits. Given the high utilization of mobile technologies, even among underserved populations and in low resource areas, mobile apps may provide a meaningful access point for all stakeholders for symptom management. OBJECTIVE: We aimed to develop a mobile app incorporating user preferences to enable cancer survivors' care partners to monitor the survivors' health and to provide care partner resources. METHODS: An iterative information gathering process was conducted that included (1) discussions with 138 stakeholders to identify challenges and gaps in survivor home care; (2) semistructured interviews with clinicians (n=3), cancer survivors (n=3), and care partners (n=3) to identify specific needs; and (3) a 28-day feasibility field test with seven care partners. RESULTS: Health professionals noted the importance of identifying early symptoms of adverse events. Survivors requested modules on medication, diet, self-care, reminders, and a version in Spanish. Care partners preferred to focus primarily on the patient's health and not their own. The app was developed incorporating quality-of-life surveys and symptom reporting, as well as resources on home survivor care. Early user testing demonstrated ease of use and app feasibility. CONCLUSIONS: TOGETHERCare, a novel mobile app, was developed with user input to track the care partner's health and report on survivor symptoms during home care. The following two clinical benefits emerged: (1) reduced anxiety among care partners who use the app and (2) the potential for identifying survivor symptoms noted by the care partner, which might prevent adverse events. TRIAL REGISTRATION: ClinicalTrials.gov NCT04018677; https://clinicaltrials.gov/ct2/show/NCT04018677.

Use of Social Media for Cancer Prevention Through Neighborhood Social Cohesion: Protocol for a Feasibility Study.

BACKGROUND: Social cohesion is associated with healthier behaviors and better health outcomes, and therefore may offer a mechanism for promoting better health. Low socioeconomic status (SES) communities face higher rates of chronic disease due to both community- and individual-level factors. OBJECTIVE: The aim of this study is to leverage social cohesion to promote healthier behaviors and prevent chronic disease in a low SES community. This protocol outlines the methodology for a pilot study to assess the feasibility of an intervention (Free Time For Wellness [FT4W]) using a social networking platform (Nextdoor) with mothers living in an urban, low-income community to improve social cohesion and promote healthy behaviors. METHODS: The study will involve three phases: (I) co-designing the intervention with mothers in the neighborhoods of interest, (II) implementing the intervention with community leaders through the social networking platform, and (III) evaluating the intervention's feasibility. Phase I of the study will include qualitative data collection and analysis from in-depth, semistructured interviews and a co-design group session with mothers. Phases II and III of the study include a pre- and postintervention survey of participating mothers. Neighborhood-level data on social cohesion will also be collected to enable comparison of outcomes between neighborhoods with higher and lower baseline social cohesion. RESULTS: As of March 2021, recruitment and data collection for this study are complete. This protocol outlines our original study plan, although the final enrollment numbers and intervention implementation deviated from our initial planned methodology that is outlined in this protocol. These implementation learnings will be shared in subsequent publications of our study results. CONCLUSIONS: Ultimately, this study aims to: (1) determine the barriers and facilitators to finding free time for wellness among a population of low-income mothers to inform the co-design process, and (2) implement and study the feasibility of an intervention that leverages social cohesion to promote physical activity in a community of low-income mothers. The results of this study will provide preliminary feasibility evidence to inform a larger effectiveness trial, and will further our understanding of how social cohesion might influence well-being. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/28147.

Socioeconomic gradients in cancer incidence by race and ethnicity in California, 2008-2012: the influence of tobacco use or screening detectable cancers.

PURPOSE: There are clearly documented inequalities in cancer incidence by socioeconomic position, but it is unclear whether this is due primarily to differences in tobacco exposure and screening practices or to other factors. METHODS: Our study included 741,373 incident cases of invasive cancer from 2008 to 2012 in California. We calculated age-standardized incidence rates across twelve categories of census tract poverty as a measure of socioeconomic position (SEP) for (1) all cancer sites combined, (2) sites not strongly related to tobacco use, (3) sites not related to screening, and (4) sites not related to tobacco use or screening. RESULTS: There was higher cancer incidence among those living in areas with higher levels of poverty for sites not strongly related to tobacco use or screening, among Whites, Blacks, and Asians, but not among Latinos. Among Whites there was no relationship with census tract poverty at lower levels of poverty-the relationship with cancer incidence was primarily among those in higher poverty. For Blacks and Asians, there is a more linear relationship with cancer incidence across levels of poverty. CONCLUSIONS: SEP gradients in cancer incidence remain after exclusion of cancer sites strongly related to tobacco use and screening. Our findings demonstrate a need for research on other environmental and social causes of cancer where exposures are differentially distributed by SEP.

Data-adaptive multi-locus association testing in subjects with arbitrary genealogical relationships.

Genome-wide sequencing enables evaluation of associations between traits and combinations of variants in genes and pathways. But such evaluation requires multi-locus association tests with good power, regardless of the variant and trait characteristics. And since analyzing families may yield more power than analyzing unrelated individuals, we need multi-locus tests applicable to both related and unrelated individuals. Here we describe such tests, and we introduce SKAT-X, a new test statistic that uses genome-wide data obtained from related or unrelated subjects to optimize power for the specific data at hand. Simulations show that: a) SKAT-X performs well regardless of variant and trait characteristics; and b) for binary traits, analyzing affected relatives brings more power than analyzing unrelated individuals, consistent with previous findings for single-locus tests. We illustrate the methods by application to rare unclassified missense variants in the tumor suppressor gene BRCA2, as applied to combined data from prostate cancer families and unrelated prostate cancer cases and controls in the Multi-ethnic Cohort (MEC). The methods can be implemented using open-source code for public use as the R-package GATARS (Genetic Association Tests for Arbitrarily Related Subjects) .

Evaluation of a Mobile Device Survey System for Behavioral Risk Factors (SHAPE): App Development and Usability Study.

BACKGROUND: Risk factors, including limited exercise, poor sleep, smoking, and alcohol and drug use, if mitigated early, can improve long-term health. Risk prevalence has traditionally been measured using methods that now have diminished participation rates. With >75% of American citizens owning smartphones, new data collection methods using mobile apps can be evaluated. OBJECTIVE: The objective of our study was to describe the development, implementation, and evaluation of a mobile device-based survey system for behavioral risk assessment. Specifically, we evaluated its feasibility, usability, acceptability, and validity. METHODS: We enrolled 536 students from 3 Vermont State Colleges. Iterative mobile app development incorporated focus groups, extensive testing, and the following 4 app versions: iOS standard, iOS gamified, Android standard, and Android gamified. We aimed to capture survey data, paradata, and ambient data such as geolocation. Using 3 separate surveys, we asked a total of 27 questions that included demographic characteristics, behavioral health, and questions regarding the app's usability and survey process. RESULTS: Planned enrollment was exceeded in just a few days. There were 1392 "hits" to the landing page where the app could be downloaded. Excluding known project testers and others not part of the study population, 670 participants downloadeded the SHAPE app. Of those, 94.9% of participants (636/670) agreed to participate by providing in-app consent. Of the 636 who provided consent, 84.3% (536/636) were deemed eligible for the study. The majority of eligible respondents completed the initial survey (459/536, 85.6%), whereas 29.9% (160/536) completed the second survey and 28.5% (153/536) completed the third survey. The SHAPE survey obtained 414 participants on the behavioral risk items in survey 1, which is nearly double the 209 participants who completed the traditional Vermont College Health Survey in 2014. SHAPE survey responses were consistent with the traditionally collected Vermont College Health Survey data. CONCLUSIONS: This study provides data highlighting the potential for mobile apps to improve population-based health, including an assessment of recruitment methods, burden and response rapidity, and future adaptations. Although gamification and monetary rewards were relatively unimportant to this study population, item response theory may be technologically feasible to reduce individual survey burden. Additional data collected by smartphones, such as geolocation, could be important in additional analysis, such as neighborhood characteristics and their impact on behavioral risk factors. Mobile tools that offer rapid adaptation for specific populations may improve research data collection for primary prevention and could be used to improve engagement and health outcomes.