Development of a Control-Oriented Model of Social Cognitive Theory for Optimized mHealth Behavioral Interventions.

Mobile health (mHealth) technologies are contributing to the increasing relevance of control engineering principles in understanding and improving health behaviors, such as physical activity. Social Cognitive Theory (SCT), one of the most influential theories of health behavior, has been used as the conceptual basis for behavioral interventions for smoking cessation, weight management, and other health-related outcomes. This paper presents a control-oriented dynamical systems model of SCT based on fluid analogies that can be used in system identification and control design problems relevant to the design and analysis of intensively adaptive interventions. Following model development, a series of simulation scenarios illustrating the basic workings of the model are presented. The model's usefulness is demonstrated in the solution of two important practical problems: 1) semiphysical model estimation from data gathered in a physical activity intervention (the MILES study) and 2) as a means for discerning the range of "ambitious but doable" daily step goals in a closed-loop behavioral intervention aimed at sedentary adults. The model is the basis for ongoing experimental validation efforts, and should encourage additional research in applying control engineering technologies to the social and behavioral sciences.

Blood Pressure, Sexual Activity, and Erectile Function in Hypertensive Men: Baseline Findings from the Systolic Blood Pressure Intervention Trial (SPRINT).

INTRODUCTION: Erectile function, an important aspect of quality of life, is gaining increased research and clinical attention in older men with hypertension. AIM: To assess the cross-sectional association between blood pressure measures (systolic blood pressure [SBP]; diastolic blood pressure [DBP]; and pulse pressure [PP]) and (i) sexual activity and (ii) erectile function in hypertensive men. METHODS: We performed analyses of 1,255 male participants in a larger randomized clinical trial of 9,361 men and women with hypertension aged ≥50 years. MAIN OUTCOME MEASURES: The main outcome measures were self-reported sexual activity (yes/no) and erectile function using the 5-item International Index of Erectile Function (IIEF-5). RESULTS: 857 participants (68.3%) reported being sexually active during the previous 4 weeks. The mean (SD) IIEF-5 score for sexually active participants was 18.0 (5.8), and 59.9% of the sample reported an IIEF-5 score <21, suggesting erectile dysfunction (ED). In adjusted logistic regression models, neither SBP (adjusted odds ratio = 0.998; P = .707) nor DBP (adjusted odds ratio = 1.001; P = .929) was significantly associated with sexual activity. In multivariable linear regression analyses in sexually active participants, lower SBP (ß = -0.04; P = .025) and higher DBP (ß = 0.05; P = .029) were associated with better erectile function. In additional multivariable analyses, lower PP pressure was associated with better erectile function (ß = -0.04; P = .02). CLINICAL IMPLICATIONS: Blood pressure is an important consideration in the assessment of erectile function in men with hypertension. STRENGTHS & LIMITATIONS: Assessments of blood pressure and clinical and psychosocial variables were performed using rigorous methods in this multi-ethnic and geographically diverse sample. However, these cross-sectional analyses did not include assessment of androgen or testosterone levels. CONCLUSIONS: Erectile dysfunction was highly prevalent in this sample of men with hypertension, and SBP, DBP, and PP were associated with erectile function in this sample. Foy CG, Newman JC, Berlowitz DR, et al. Blood Pressure, Sexual Activity, and Erectile Function in Hypertensive Men: Baseline Findings from the Systolic Blood Pressure Intervention Trial (SPRINT). J Sex Med 2019;16:235-247.

Key milestones during 40 years of behavioral medicine at the National Institutes of Health.

The National Institutes of Health (NIH) has played a major role in promoting behavioral medicine research over the past 40 years through funding, review, and priority-setting activities and programs including scientific conferences, meetings, workgroups, intramural research, and training opportunities. In this review of NIH activities in support of behavioral medicine over the past four decades, we highlight key events, programs, projects, and milestones that demonstrate the many ways in which the NIH has supported behavioral and social sciences research and advanced the public health while contributing to the evolution of behavioral medicine as a scientific field.

Blood Pressure, Sexual Activity, and Dysfunction in Women With Hypertension: Baseline Findings From the Systolic Blood Pressure Intervention Trial (SPRINT).

INTRODUCTION: Sexual function, an important component of quality of life, is gaining increased research and clinical attention in older women with hypertension. AIM: To assess the association between systolic blood pressure (SBP) and other variables, and sexual activity and sexual dysfunction in hypertensive women. METHODS: Baseline analysis of 635 women participants of a larger randomized clinical trial of 9361 men and women. MAIN OUTCOME MEASURES: Self-reported sexual activity (yes/no), and sexual function using the Female Sexual Function Inventory (FSFI). RESULTS: 452 participants (71.2%) reported having no sexual activity during the previous 4 weeks. The mean (SD) FSFI score for sexually active participants was 25.3 (6.0), and 52.6% of the sample reported a FSFI score ≤26.55 designating sexual dysfunction. In logistic regression models, SBP was not significantly associated with sexual activity (AOR = 1.002; P > .05). Older age (AOR = 0.95, P < .05), and lower education (AOR for < high school vs college degree = 0.29, P < .05) were associated with lower odds of being sexually active, as was living alone versus living with others (AOR = 0.56, P < .05). Higher weekly alcohol consumption was associated with increased odds of being sexually active (AOR = 1.39; P < .05). In logistic regression models among sexually active participants, SBP was not associated with sexual dysfunction (AOR = 1.01; P > .05). Higher depressive symptoms from the Patient Health Questionnaire-9 (PHQ-9) was associated with higher odds of sexual dysfunction (AOR = 1.24, P < .05), as was increased number of physical comorbidities (AOR = 1.25, P < .05). Diuretic use was associated with lower odds of being sexually active in participants with chronic kidney disease (AOR = 0.33, P < .05). CONCLUSION: Younger age, higher education, living with others, and higher weekly alcohol consumption were significantly associated with higher odds of being sexually active in a sample of middle-aged and older women with hypertension. Increased depressive symptoms and increased physical comorbidities were significantly associated with increased odds of sexual dysfunction. SBP was not significantly associated with sexual activity or sexual dysfunction.

Willingness to Exchange Health Information via Mobile Devices: Findings From a Population-Based Survey.

PURPOSE: The rapid proliferation of mobile devices offers unprecedented opportunities for patients and health care professionals to exchange health information electronically, but little is known about patients' willingness to exchange various types of health information using these devices. We examined willingness to exchange different types of health information via mobile devices, and assessed whether sociodemographic characteristics and trust in clinicians were associated with willingness in a nationally representative sample. METHODS: We analyzed data for 3,165 patients captured in the 2013 Health Information National Trends Survey. Multinomial logistic regression analysis was conducted to test differences in willingness. Ordinal logistic regression analysis assessed correlates of willingness to exchange 9 types of information separately. RESULTS: Participants were very willing to exchange appointment reminders (odds ratio [OR] = 6.66; 95% CI, 5.68-7.81), general health tips (OR = 2.03; 95% CI, 1.74-2.38), medication reminders (OR = 2.73; 95% CI, 2.35-3.19), laboratory/test results (OR = 1.76; 95% CI, 1.62-1.92), vital signs (OR = 1.63; 95% CI, 1.48-1.80), lifestyle behaviors (OR = 1.40; 95% CI, 1.24-1.58), and symptoms (OR = 1.62; 95% CI, 1.46-1.79) as compared with diagnostic information. Older adults had lower odds of being more willing to exchange any type of information. Education, income, and trust in health care professional information correlated with willingness to exchange certain types of information. CONCLUSIONS: Respondents were less willing to exchange via mobile devices information that may be considered sensitive or complex. Age, socioeconomic factors, and trust in professional information were associated with willingness to engage in mobile health information exchange. Both information type and demographic group should be considered when developing and tailoring mobile technologies for patient-clinician communication.

Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies.

In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.

Program evaluation of remote heart failure monitoring: healthcare utilization analysis in a rural regional medical center.

BACKGROUND: Remote monitoring for heart failure (HF) has had mixed and heterogeneous effects across studies, necessitating further evaluation of remote monitoring systems within specific healthcare systems and their patient populations. "Care Beyond Walls and Wires," a wireless remote monitoring program to facilitate patient and care team co-management of HF patients, served by a rural regional medical center, provided the opportunity to evaluate the effects of this program on healthcare utilization. MATERIALS AND METHODS: Fifty HF patients admitted to Flagstaff Medical Center (Flagstaff, AZ) participated in the project. Many of these patients lived in underserved and rural communities, including Native American reservations. Enrolled patients received mobile, broadband-enabled remote monitoring devices. A matched cohort was identified for comparison. RESULTS: HF patients enrolled in this program showed substantial and statistically significant reductions in healthcare utilization during the 6 months following enrollment, and these reductions were significantly greater compared with those who declined to participate but not when compared with a matched cohort. CONCLUSIONS: The findings from this project indicate that a remote HF monitoring program can be successfully implemented in a rural, underserved area. Reductions in healthcare utilization were observed among program participants, but reductions were also observed among a matched cohort, illustrating the need for rigorous assessment of the effects of HF remote monitoring programs in healthcare systems.

From Big Data to Knowledge in the Social Sciences.

One of the challenges associated with high-volume, diverse datasets is whether synthesis of open data streams can translate into actionable knowledge. Recognizing that challenge and other issues related to these types of data, the National Institutes of Health developed the Big Data to Knowledge or BD2K initiative. The concept of translating "big data to knowledge" is important to the social and behavioral sciences in several respects. First, a general shift to data-intensive science will exert an influence on all scientific disciplines, but particularly on the behavioral and social sciences given the wealth of behavior and related constructs captured by big data sources. Second, science is itself a social enterprise; by applying principles from the social sciences to the conduct of research, it should be possible to ameliorate some of the systemic problems that plague the scientific enterprise in the age of big data. We explore the feasibility of recalibrating the basic mechanisms of the scientific enterprise so that they are more transparent and cumulative; more integrative and cohesive; and more rapid, relevant, and responsive.

Analysis of the health economics portfolio funded by the National Institutes of Health in response to published guidance.

Health services, economics, and outcomes research (referred to as health economics research hereinafter) is one of the interdisciplinary sciences that the National Institutes of Health (NIH) supports in order to pursue its overall mission to improve health. In 2015, NIH guidance was published to clarify the type of health economics research that NIH would continue to fund. This analysis aimed to determine if there were changes in the number of health economics applications received and funded by NIH after the release of the guidance. Health economics applications submitted to NIH both before and after publication of the guidance were identified using a machine learning approach with input from subject matter experts. Application and funding trends were examined by fiscal year, method of application (solicited vs. unsolicited), and activity code. This study found that application and funding rates of health economics research were decreasing prior to guidance. Following publication of this guidance, the application and funding rate of health economics applications increased.

Upper-extremity and mobility subdomains from the Patient-Reported Outcomes Measurement Information System (PROMIS) adult physical functioning item bank.

OBJECTIVE: To create upper-extremity and mobility subdomain scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning adult item bank. DESIGN: Expert reviews were used to identify upper-extremity and mobility items from the PROMIS item bank. Psychometric analyses were conducted to assess empirical support for scoring upper-extremity and mobility subdomains. SETTING: Data were collected from the U.S. general population and multiple disease groups via self-administered surveys. PARTICIPANTS: The sample (N=21,773) included 21,133 English-speaking adults who participated in the PROMIS wave 1 data collection and 640 Spanish-speaking Latino adults recruited separately. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We used English- and Spanish-language data and existing PROMIS item parameters for the physical functioning item bank to estimate upper-extremity and mobility scores. In addition, we fit graded response models to calibrate the upper-extremity items and mobility items separately, compare separate to combined calibrations, and produce subdomain scores. RESULTS: After eliminating items because of local dependency, 16 items remained to assess upper extremity and 17 items to assess mobility. The estimated correlation between upper extremity and mobility was .59 using existing PROMIS physical functioning item parameters (r=.60 using parameters calibrated separately for upper-extremity and mobility items). CONCLUSIONS: Upper-extremity and mobility subdomains shared about 35% of the variance in common, and produced comparable scores whether calibrated separately or together. The identification of the subset of items tapping these 2 aspects of physical functioning and scored using the existing PROMIS parameters provides the option of scoring these subdomains in addition to the overall physical functioning score.

Advancing digital health equity: Directions for behavioral and social science research.

The field of digital health is evolving rapidly and encompasses a wide range of complex and changing technologies used to support individual and population health. The COVID-19 pandemic has augmented digital health expansion and significantly changed how digital health technologies are used. To ensure that these technologies do not create or exacerbate existing health disparities, a multi-pronged and comprehensive research approach is needed. In this commentary, we outline five recommendations for behavioral and social science researchers that are critical to promoting digital health equity. These recommendations include: (i) centering equity in research teams and theoretical approaches, (ii) focusing on issues of digital health literacy and engagement, (iii) using methods that elevate perspectives and needs of underserved populations, (iv) ensuring ethical approaches for collecting and using digital health data, and (v) developing strategies for integrating digital health tools within and across systems and settings. Taken together, these recommendations can help advance the science of digital health equity and justice.

The field of digital health is quickly growing and changing. Digital health technologies have the potential to increase access to health-related information and healthcare and improve wellbeing, but it is important that those technologies don't widen existing health disparities or create new ones. Behavioral and social science researchers have a key role to play in centering equity in their research teams and theoretical approaches, focusing on key barriers to access, uptake, and usage, studying digital health in ways that elevate the voices and needs of historically underserved groups, being thoughtful about how digital health data are collected and used, and making sure that digital health tools are designed to be used in real-world settings.

Advancing the science of mHealth.

Mobile health (mHealth) technologies have the potential to greatly impact health research, health care, and health outcomes, but the exponential growth of the technology has outpaced the science. This article outlines two initiatives designed to enhance the science of mHealth. The mHealth Evidence Workshop used an expert panel to identify optimal methodological approaches for mHealth research. The NIH mHealth Training Institutes address the silos among the many academic and technology areas in mHealth research and is an effort to build the interdisciplinary research capacity of the field. Both address the growing need for high quality mobile health research both in the United States and internationally. mHealth requires a solid, interdisciplinary scientific approach that pairs the rapid change associated with technological progress with a rigorous evaluation approach. The mHealth Evidence Workshop and the NIH mHealth Training Institutes were both designed to address and further develop this scientific approach to mHealth.

Ending Sexual Harassment in Science: Designing and Administering a Survey That Can Lead to an Improved Organizational Climate.

Workplace harassment, particularly sexual harassment, has substantial negative implications for individuals and organizations and for scientific advancement. The National Institutes of Health (NIH) is uniquely positioned to lead the effort to prevent sexual harassment in the scientific community and mitigate its detrimental effects. Recognizing the need for benchmark data, NIH developed and validated the 2019 NIH Workplace Climate and Harassment Survey. The goal was to use best practices in survey design methods to create an instrument for rigorous assessment of harassment incidence and organizational climate predictors of sexual harassment in scientific research environments. This article summarizes the processes used to design and administer the NIH survey and provides brief descriptions of 3 products of the process developed to guide scientific institutions wishing to embark on a data-driven approach to assess and prevent harassment: a document detailing survey development and methods, a survey implementation guide, and the key findings obtained from the survey, including recommendations for interventions targeting the organizational climate at NIH and limitations of the survey. The survey identified that 1 in 5 respondents had experienced sexual harassment in the 12 months preceding their participation in the survey and that women, sexual and gender minorities, younger respondents, trainees/students, and individuals with a disability were more likely to have experienced sexual harassment. Those who had experienced sexual harassment during that period were also more likely to have experienced incivility, bullying, and intimidating behaviors in the workplace. NIH intends to use the survey findings as a quality assurance and quality improvement guide to inform future activities to prevent and address harassment across NIH.

Application of the National Institutes of Health Patient-reported Outcome Measurement Information System (PROMIS) to mental health research.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) is a National Institutes of Health initiative to develop item banks measuring patient-reported outcomes (PROs) and to create and make available a computerized adaptive testing system (CAT) that allows for efficient and precise assessment of PROs in clinical research and practice. AIMS OF THE STUDY: This paper provides an overview of PROMIS and its application to mental health research. METHODS: The PROMIS methodology for item bank development and testing is described, with a focus on the implications of this work for mental health research. RESULTS: Utilizing qualitative item review and state-of-the-art applications of item response theory (IRT), PROMIS investigators have developed, tested, and released item banks measuring physical, mental, and social health components. Ongoing efforts continue to add new item banks and further validate existing banks. DISCUSSION: PROMIS provides item banks measuring several domains of interest to mental health researchers including emotional distress, social function, and sleep. PROMIS methodology also provides a rigorous standard for the development of new mental health measures. IMPLICATIONS FOR HEALTH CARE PROVISION: Web-based CAT or administration of short forms derived from PROMIS item banks provide efficient and precise dimensional estimates of clinical outcomes that can be utilized to monitor patient progress and assess quality improvement. IMPLICATIONS FOR FUTURE RESEARCH: Use of the dimensional PROMIS metrics (and co-calibration of the PROMIS item banks with existing PROs) will allow comparisons of mental health and related health outcomes across disorders and studies.

Social Determinants of Health and Implementation Research: Lessons from the COVID-19 Pandemic.

During the past three decades, the world has experienced many clinical and public health challenges that require implementation of practices and policies informed by an understanding of social determinants of health and health inequities, but perhaps none as global and pervasive as the current COVID-19 pandemic. In the context of this special themed issue on Social Determinants of Health and Implementation Research: Three Decades of Progress and a Need for Convergence, we highlight the application of social determinants of health and implementation research on various aspects of the COVID-19 pandemic.

Patient-reported outcomes measurement information system (PROMIS) domain names and definitions revisions: further evaluation of content validity in IRT-derived item banks.

PURPOSE: Content validity of patient-reported outcomes (PROs) is evaluated primarily during item development, but subsequent psychometric analyses, particularly for item response theory (IRT)-derived scales, often result in considerable item pruning and potential loss of content. After selecting items for the PROMIS banks based on psychometric and content considerations, we invited external content expert reviews of the degree to which the initial domain names and definitions represented the calibrated item bank content. METHODS: A minimum of four content experts reviewed each item bank and recommended a domain name and definition based on item content. Domain names and definitions then were revealed to the experts who rated how well these names and definitions fit the bank content and provided recommendations for definition revisions. RESULTS: These reviews indicated that the PROMIS domain names and definitions remained generally representative of bank content following item pruning, but modifications to two domain names and minor to moderate revisions of all domain definitions were needed to optimize fit with the item bank content. CONCLUSIONS: This reevaluation of domain names and definitions following psychometric item pruning, although not previously documented in the literature, appears to be an important procedure for refining conceptual frameworks and further supporting content validity.