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.

The Indian Health Service Primary Care-Based Teleophthalmology Program for Diabetic Eye Disease Surveillance and Management.

Background: Historically, fewer than half of American Indians and Alaska Natives (AI/AN) with diabetes received the annual diabetic retinopathy (DR) examination that is considered the minimum standard of care; this rate is similar to that of the general United States (U.S.) population with diabetes. Solution: The Indian Health Service-Joslin Vision Network (IHS-JVN) Teleophthalmology Program in 2000 to increase compliance with DR standards of care among AI/AN through validated, primary care-based telemedicine. The IHS-JVN provides remote diagnosis of DR severity, with a report including management recommendations that is returned to the patient's primary care provider. The program conforms with the American Telemedicine Association (ATA) Practice Guidelines for Ocular Telehealth-Diabetic Retinopathy. Outcomes: The IHS-JVN has been expanding incrementally since the first patients were recruited in 2000; this expansion coincides with large improvements in the annual DR examination rates reported as part of local, regional, and national regulatory compliance under the Government Performance and Results Act (GPRA). Currently, with 99 clinical implementations in 23 states, IHS-JVN is the largest primary care-based ATA validation category three telemedicine program in the U.S. Summary: This article describes the program's workflow, imaging and reading technologies, diagnostic protocols, reports to providers, training, quality assurance processes, and geographical distribution. In addition to its clinical use, the program has been utilized in research on utilization of diabetic eye care, cost-effectiveness, technology development, and DR epidemiology of the AI/AN population. Potential next steps for this program are discussed.

Advanced Digital Health Technologies for COVID-19 and Future Emergencies.

Background: Coronavirus disease 2019 (COVID-19) has led to a national health care emergency in the United States and exposed resource shortages, particularly of health care providers trained to provide critical or intensive care. This article describes how digital health technologies are being or could be used for COVID-19 mitigation. It then proposes the National Emergency Tele-Critical Care Network (NETCCN), which would combine digital health technologies to address this and future crises. Methods: Subject matter experts from the Society of Critical Care Medicine and the Telemedicine and Advanced Technology Research Center examined the peer-reviewed literature and science/technology news to see what digital health technologies have already been or could be implemented to (1) support patients while limiting COVID-19 transmission, (2) increase health care providers' capability and capacity, and (3) predict/prevent future outbreaks. Results: Major technologies identified included telemedicine and mobile care (for COVID-19 as well as routine care), tiered telementoring, telecritical care, robotics, and artificial intelligence for monitoring. Several of these could be assimilated to form an interoperable scalable NETCCN. NETCCN would assist health care providers, wherever they are located, by obtaining real-time patient and supplies data and disseminating critical care expertise. NETCCN capabilities should be maintained between disasters and regularly tested to ensure continual readiness. Conclusions: COVID-19 has demonstrated the impact of a large-scale health emergency on the existing infrastructures. Short term, an approach to meeting this challenge is to adopt existing digital health technologies. Long term, developing a NETCCN may ensure that the necessary ecosystem is available to respond to future emergencies.

Extracellular carbonic anhydrase mediates hemorrhagic retinal and cerebral vascular permeability through prekallikrein activation.

Excessive retinal vascular permeability contributes to the pathogenesis of proliferative diabetic retinopathy and diabetic macular edema, leading causes of vision loss in working-age adults. Using mass spectroscopy-based proteomics, we detected 117 proteins in human vitreous and elevated levels of extracellular carbonic anhydrase-I (CA-I) in vitreous from individuals with diabetic retinopathy, suggesting that retinal hemorrhage and erythrocyte lysis contribute to the diabetic vitreous proteome. Intravitreous injection of CA-I in rats increased retinal vessel leakage and caused intraretinal edema. CA-I-induced alkalinization of vitreous increased kallikrein activity and its generation of factor XIIa, revealing a new pathway for contact system activation. CA-I-induced retinal edema was decreased by complement 1 inhibitor, neutralizing antibody to prekallikrein and bradykinin receptor antagonism. Subdural infusion of CA-I in rats induced cerebral vascular permeability, suggesting that extracellular CA-I could have broad relevance to neurovascular edema. Inhibition of extracellular CA-I and kallikrein-mediated innate inflammation could provide new therapeutic opportunities for the treatment of hemorrhage-induced retinal and cerebral edema.

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.

Randomized Controlled Trial of Telementoring During Resource-Limited Patient Care Simulation Improves Caregiver Performance and Patient Survival.

OBJECTIVES: To determine the impact of telementoring on caregiver performance during a high-fidelity medical simulation model (HFMSM) of a critically ill patient in a resource-limited setting. DESIGN: A two-center, randomized, controlled study using a HFMSM of a patient with community-acquired pneumonia complicated by acute respiratory distress syndrome. SETTING: A notional clinic in a remote location staffed by a single clinician and nonmedical assistant. PARTICIPANTS: Clinicians with limited experience managing critically ill patients. INTERVENTIONS: Telemedicine (TM) support. MEASUREMENTS: The primary outcome was clinical performance as measured by accuracy, reliability, and efficiency of care. Secondary outcomes were patient survival, procedural quality, subjective assessment of the HFMSM, and perceived workload. MAIN RESULTS: TM participants (N = 11) performed better than non-TM (NTM, N = 12) in providing expected care (accuracy), delivering care more consistently (reliability), and without consistent differences in efficiency (timeliness of care). Accuracy: TM completed 91% and NTM 42% of expected tasks and procedures. Efficiency: groups did not differ in the mean (± sd) minutes it took to obtain an advanced airway successfully (TM 15.2 ± 10.5 vs. NTM 22.8 ± 8.4, p = 0.10) or decompress a tension pneumothorax with a needle (TM 0.7 ± 0.5 vs. NTM 0.6 ± 0.9, p = 0.65). TM was slower than NTM in completing thoracostomy (22.3 ± 10.2 vs. 12.3 ± 4.8, p = 0.03). Reliability: TM performed 13 of 17 (76%) tasks with more consistent timing than NTM. TM completed 68% and NTM 29% of procedural quality metrics. Eighty-two percent of the TM participants versus 17% of the NTM participants simulated patients survived (p = 0.003). The groups similarly perceived the HFMSM as realistic, managed their patients with personal ownership, and experienced comparable workload and stress. CONCLUSIONS: Remote expertise provided with TM to caregivers in resource-limited settings improves caregiver performance, quality of care, and potentially real patient survival. HFMSM can be used to study interventions in ways not possible with real patients.

Effect of an accelerometer on body weight and fitness in overweight and obese active duty soldiers.

This study evaluated whether using a web-linked accelerometer, plus mandatory physical training, is associated with various weight- and fitness-related outcomes in overweight/obese active duty soldiers. Soldiers who failed the height/weight standards of the Army Physical Fitness Test (APFT) were randomized to use a Polar FA20 accelerometer device (polar accelerometer group [PA], n = 15) or usual care (UC, n = 13) for 6 months. Both groups received 1.5 hours of lifestyle instruction. We collected data at baseline, 2, 4, and 6 months, and evaluated group differences in temporal changes in study outcomes. At 6 months, 1/28 subjects (UC) passed the APFT height/weight standards. There were no group differences in changes in weight (PA: -0.1 kg vs. UC: +0.3 kg; p = 0.9), body fat (PA: -0.9% vs. UC: -1.1%; p = 0.9), systolic blood pressure (PA: +1.3 mm Hg vs. UC: -2.1 mm Hg; p = 0.2), diastolic blood pressure (PA: +3.8 mm Hg vs. UC: -2.4 mm Hg; p = 0.3), or resting heart rate in beats per minute (bpm) (PA: +7.8 bpm vs. UC: +0.1 bpm; p = 0.2). These results suggest that using an accelerometer with web-based feedback capabilities plus mandatory physical training does not assist in significant weight loss or ability to pass the APFT height/weight standards among overweight/obese soldiers.

Incidence and Progression of Diabetic Retinopathy in American Indian and Alaska Native Individuals Served by the Indian Health Service, 2015-2019.

Importance: Estimates of diabetic retinopathy (DR) incidence and progression in American Indian and Alaska Native individuals are based on data from before 1992 and may not be informative for strategizing resources and practice patterns. Objective: To examine incidence and progression of DR in American Indian and Alaska Native individuals. Design, Setting, and Participants: This was a retrospective cohort study conducted from January 1, 2015, to December 31, 2019, and included adults with diabetes and no evidence of DR or mild nonproliferative DR (NPDR) in 2015 who were reexamined at least 1 time during the 2016 to 2019 period. The study setting was the Indian Health Service (IHS) teleophthalmology program for diabetic eye disease. Exposure: Development of new DR or worsening of mild NPDR in American Indian and Alaska Native individuals with diabetes. Main Outcomes and Measures: Outcomes were any increase in DR, 2 or more (2+) step increases, and overall change in DR severity. Patients were evaluated with nonmydriatic ultra-widefield imaging (UWFI) or nonmydriatic fundus photography (NMFP). Standard risk factors were included. Results: The total cohort of 8374 individuals had a mean (SD) age of 53.2 (12.2) years and a mean (SD) hemoglobin A1c level of 8.3% (2.2%) in 2015, and 4775 were female (57.0%). Of patients with no DR in 2015, 18.0% (1280 of 7097) had mild NPDR or worse in 2016 to 2019, and 0.1% (10 of 7097) had PDR. The incidence rate from no DR to any DR was 69.6 cases per 1000 person-years at risk. A total of 6.2% of participants (441 of 7097) progressed from no DR to moderate NPDR or worse (ie, 2+ step increase; 24.0 cases per 1000 person-years at risk). Of patients with mild NPDR in 2015, 27.2% (347 of 1277) progressed to moderate NPDR or worse in 2016 to 2019, and 2.3% (30 of 1277) progressed to severe NPDR or worse (ie, 2+ step progression). Incidence and progression were associated with expected risk factors and evaluation with UWFI. Conclusions and Relevance: In this cohort study, the estimates of DR incidence and progression were lower than those previously reported for American Indian and Alaska Native individuals. The results suggest extending the time between DR re-evaluations for certain patients in this population, if follow-up compliance and visual acuity outcomes are not jeopardized.

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.

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.

Evolution of a web-based, prototype Personal Health Application for diabetes self-management.

Behaviors carried out by the person with diabetes (e.g., healthy eating, physical activity, judicious use of medication, glucose monitoring, coping and problem-solving, regular clinic visits, etc.) are of central importance in diabetes management. To assist with these behaviors, we developed a prototype PHA for diabetes self-management that was based on User-Centered Design principles and congruent with the anticipatory vision of Project Health Design (PHD). This article presents aspects of the prototype PHA's functionality as conceived under PHD and describes modifications to the PHA now being undertaken under new sponsorship, in response to user feedback and timing tests we have performed. In brief, the prototype Personal Health Application (PHA) receives data on the major diabetes management domains from a Personal Health Record (PHR) and analyzes and provides feedback based on clinically vetted educational content. The information is presented within "gadgets" within a portal-based website. The PHR used for the first implementation was the Common Platform developed by PHD. Key changes include a re-conceptualization of the gadgets by topic areas originally defined by the American Association of Diabetes Educators, a refocusing on low-cost approaches to diabetes monitoring and data entry, and synchronization with a new PHR, Microsoft® HealthVault™.

Combining iGoogle and personal health records to create a prototype personal health application for diabetes self-management.

OBJECTIVE: The aim of this project is to create a prototype for a personal health application (PHA) for patients (i.e., consumers) with diabetes by employing a user-centered design process. This article describes the design process for and resulting architecture, workflow, and functionality of such a PHA. MATERIALS AND METHODS: For the design process, we conducted focus groups with people who have diabetes (n = 21) to ascertain their needs for a PHA. We then developed a prototype in response to these needs, and through additional focus groups and step-by-step demonstrations for people with diabetes as well as healthcare providers, we obtained feedback about the prototype. The feedback led to changes in the PHA's presentation and function. RESULTS: Focus group participants said they wanted a tool that could give them timely, readily available information on how diabetes-related domains interact, how their behaviors affect them, and what to do next. Thus, the prototype PHA is Internet-based, retrieves data for diabetes self-management from a personal health record, displays those data using gadgets in the consumer's iGoogle page, and makes the data available to a decision-support component that provides lifestyle-oriented advice. Manipulation of the data enables consumers to anticipate the results of future actions and to see interrelationships. CONCLUSIONS: A user-centered design process resulted in a PHA that uses technology that is publicly available, employs a personal health record, and is Internet based. This PHA can provide the backbone for a decision support system that can bring together the cornerstones of diabetes self-management and integrate them into the life of the person with diabetes.

Usability test of an internet-based informatics tool for diabetes care providers: the comprehensive diabetes management program.

BACKGROUND: Research suggests Internet-based care management tools are associated with improvements in care and patient outcomes. However, although such tools change workflow, rarely is their usability addressed and reported. This article presents a usability study of an Internet-based informatics application called the Comprehensive Diabetes Management Program (CDMP), developed by content experts and technologists. Our aim is to demonstrate a process for conducting a usability study of such a tool and to report results. METHODS: We conducted the usability test with six diabetes care providers under controlled conditions. Each provider worked with the CDMP in a single session using a "think aloud" process. Providers performed standardized tasks with fictitious patient data, and we observed how they approached these tasks, documenting verbalizations and subjective ratings. The providers then completed a usability questionnaire and interviews. RESULTS: Overall, the scores on the usability questionnaire were neutral to favorable. For specific subdomains of the questionnaire, the providers' reported problems with the application's ease of use, performance, and support features, but were satisfied with its visual appeal and content. The results from the observational and interview data indicated areas for improvement, particularly in navigation and terminology. CONCLUSIONS: The usability study identified several issues for improvement, confirming the need for usability testing of Internet-based informatics applications, even those developed by experts. To our knowledge, there have been no other usability studies of an Internet-based informatics application with the functionality of the CDMP. Such studies can form the foundation for translation of Internet-based medical informatics tools into clinical practice.

Prevalence of diabetic retinopathy and diabetic macular edema in a primary care-based teleophthalmology program for American Indians and Alaskan Natives.

BACKGROUND: Diabetes and its complications are more common in American Indians and Alaska Natives (AI/AN) than other US racial/ethnic populations. Prior reports of diabetic retinopathy (DR) prevalence in AI/AN are dated, and research on diabetic macular edema (DME) is limited. This study characterizes the recent prevalence of DR and DME in AI/AN using primary care-based teleophthalmology surveillance. METHODS: This is a multi-site, clinic-based, cross-sectional study of DR and DME. The sample is composed of AI /AN patients with diabetes (n = 53,998), served by the nationally distributed Indian Health Service-Joslin Vision Network Teleophthalmology Program (IHS-JVN) in primary care clinics of US Indian Health Service (IHS), Tribal, and Urban Indian health care facilities (I/T/U) from 1 November 2011 to 31 October 2016. Patients were recruited opportunistically for a retinal examination using the IHS-JVN during their regular diabetes care. The IHS-JVN used clinically validated, non-mydriatic, retinal imaging and retinopathy assessment protocols to identify the severity levels of non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), DME, and sight threatening retinopathy (STR; a composite measure). Key social-demographic (age, gender, IHS area), diabetes-related health (diabetes therapy, duration of diabetes, A1c), and imaging technology variables were examined. The analysis calculated frequencies and percentages of severity levels of disease. RESULTS: Prevalence of any NPDR, PDR, DME, and STR among AI/AN patients undergoing DR teleophthalmology surveillance by IHS-JVN was 17.7%, 2.3%, 2.3%, and 4.2%, respectively. Prevalence was lowest in Alaska and highest among patients with A1c >/ = 8%, duration of diabetes > 10 years, or using insulin. CONCLUSIONS: Prevalence of DR in this cohort was approximately half that in previous reports for AI/AN, and prevalence of DME was less than that reported in non-AI/AN populations. A similar reduction in diabetes related end-stage renal disease in the same population and time period has been reported by other researchers. Since these two diabetic complications share a common microvasculopathic mechanism, this coincident change in prevalence may also share a common basis, possibly related to improved diabetes management.

Does Mobile Care ('mCare') Improve Quality of Life and Treatment Satisfaction Among Service Members Rehabilitating in the Community? Results from a 36-Wk, Randomized Controlled Trial.

Introduction: Research has shown that mobile phones can help with management of numerous health problems. As an adjunct to care management provided to injured service members rehabilitating in their communities, particularly those with mild traumatic brain injury (mTBI), post-traumatic stress (PTS), and/or behavioral health problems, the Army developed a mobile phone application called "mCare." This study examined whether service members who received mCare had higher well-being, were more satisfied with their care, and viewed mCare as a valuable part of their care management as compared with their counterparts who received standard care management alone, and whether those with mTBI, PTS, and/or behavioral health problems benefited differently from mCare. Materials and Methods: In-processing service members at four community-based warrior transition units were recruited for participation in a 36-wk, randomized, controlled trial and allocated to receive standard care management plus mCare (n = 95) or standard care management alone (n = 87). Participants in the mCare group received daily questionnaires, tips, and appointment reminders. All participants were asked to complete the General Well-being Schedule (GWS) at baseline, 12, 24, and 36 wk, and the Case Management Quality Questionnaire (CMQQ) at 12, 24, and 36 wk. All participants and care managers were approached to complete interviews about the usability/likeability of mCare or standard care management. The analyses tested for group differences in completion of the intervention, graphed means for the GWS and CMQQ by group/subgroup, and statistically compared the longitudinal trends in these outcomes using mixed models in which group, time, and group*time were included as regression variables. The analyses also tallied interview responses and identified thematic quotes. The study protocol was reviewed and approved by the Walter Reed National Military Medical Center's Institutional Review Board. Results: Estimated rate of change in GWS scores was -2.2 (standard error = 1.0; t = -2.1; p = 0.0382). Estimated rate of change in CMQQ scores was -0.8 (standard error = 0.5; t = -1.52; p = 0.1299). Neither change was meaningful. Rates of change in the GWS and CMQQ scores did not differ by group or by behavioral health, mTBI, and PTS subgroups within the groups. The interviews found that 83% of mCare participants liked the communication with their care managers versus 73% of standard care management participants. Participants in both the mCare group and the care managers said that they liked the application's appointment tracking and reminders. Care managers thought mCare was particularly useful for people with mTBI, PTS, and cognitive problems. Conclusion: mCare did not result in differences in general well-being and satisfaction with care management among service members rehabilitating in their communities, some with mTBI, PTS, and/or behavioral health problems. But participants and care managers who used mCare said that they found it useful. Study limitations included the diversity of clinical issues of the participants, greater missing data among mCare participants, and the high baseline quality of care management in the settings observed. The fact that patients and care managers liked mCare, apart from no changes in outcomes, is important because health care is increasingly adopting mobile solutions.

The Cost-Effectiveness of Real-Time Continuous Glucose Monitoring (RT-CGM) in Type 2 Diabetes.

BACKGROUND: This analysis models the cost-effectiveness of real-time continuous glucose monitoring (RT-CGM) using evidence from a randomized controlled trial (RCT) that demonstrated RT-CGM reduced A1C, for up to 9 months after using the technology, among patients with type 2 diabetes not on prandial insulin. RT-CGM was offered short-term and intermittently as a self-care tool to inform patients' behavior. METHOD: The analyses projected lifetime clinical and economic outcomes for RT-CGM versus self-monitoring of blood glucose by fingerstick only. The base-case analysis was consistent with the RCT (RT-CGM for 2 weeks on/1 week off over 3 months). A scenario analysis simulated outcomes of an RT-CGM "refresher" after the active intervention of the RCT. Analyses used the IMS CORE Diabetes Model and were conducted from a US third-party payer perspective, including direct costs obtained from published sources and inflated to 2011 US dollars. Costs and health outcomes were discounted at 3% per annum. RESULTS: Life expectancy (LE) and quality-adjusted life expectancy (QALE) from RT-CGM were 0.10 and 0.07, with a cost of $653/patient over a lifetime. Incremental LE and QALE from a "refresher" were 0.14 and 0.10, with a cost of $1312/patient over a lifetime, and incremental cost-effectiveness ratios were $9319 and $13 030 per LY and QALY gained. CONCLUSIONS: RT-CGM, as a self-care tool, is a cost-effective disease management option in the US for people with type 2 diabetes not on prandial insulin. Repeated use of RT-CGM may result in additional cost-effectiveness.

Age, hormones, and cognitive functioning among middle-aged and elderly men: cross-sectional evidence from the Massachusetts Male Aging Study.

BACKGROUND: This study examines interrelationships among age, hormones, and cognition for middle-aged and elderly men, and tests whether hormones predict lower cognitive functioning and mediate the age-cognition relationship. METHODS: We analyzed Time 2 data from the Massachusetts Male Aging Study, a population-based cohort study. Selection criteria included complete information on cognition and hormones (n = 981). Cognitive measures included working memory (Backward Digit Span test), speed/attention (Digit Symbol Substitution test), and spatial ability (Figural Relations test). Hormones included free testosterone, total testosterone, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), androstanediol glucuronide (3 alpha-A-diol-gluc), luteinizing hormone (LH), follicle-stimulating hormone (FSH), sex hormone-binding globulin (alternatively known as a "binding protein") (SHBG), prolactin (PRL), estrone (E1), and cortisol (CRT). Age was measured in years. Adjusted analyses added educational attainment, health conditions and behaviors, body mass index, and depression. RESULTS: Older age was associated with lower cognitive functioning. In unadjusted models, logged free and total testosterone, DHEA, and DHEAS related to higher functioning in at least one cognitive domain; logged FSH, SHBG, and LH related to lower functioning in at least one cognitive domain; and logged E1, CRT, and PRL were not significant. In adjusted models, logged hormones did not relate to cognitive function except for logged E1 and CRT, which had negative effects. Logged hormones did not mediate the age-cognition relationship. CONCLUSIONS: The direct effects of hormones on cognition are not significant when salient factors are considered. Further, hormones do not mediate the age-cognition relationship; it is necessary to look to other explanatory pathways.

Patterns in functioning among residents of an affordable assisted living housing facility.

PURPOSE: This is the second article reporting a project that (a) characterized the longitudinal functional patterns of residents in an affordable, assisted living housing (ALH) milieu for low-income people and (b) compared the ALH residents' functional patterns with those for similarly low-income, community-dwelling people. DESIGN AND METHODS: Functioning was defined as the ability to perform activities of daily living and instrumental activities of daily living and respondents' competing risks such as death and institutionalization. The comparison samples were selected from the Health and Retirement Study (HRS) and the Asset and Health Dynamics Among the Oldest Old (AHEAD) study. The analyses involved description of functional patterns and multinomial logit models to assess the relative likelihood that study participants experienced each pattern of functioning and competing risks. RESULTS: About 42.4% of the ALH residents had stable high functioning, 32.9% deteriorated (e.g., had increased impairment, institutionalization, death), 3% improved in functioning, 6% exhibited moderate to severe impairment throughout the study, and the remainder returned to the community. Comparison of the ALH residents' functional patterns with those of the community-dwelling respondents indicated that the ALH residents' patterns generally were similar and in some ways better, adjusting for social-demographic factors and health; for example, the ALH residents were no different (statistically) in terms of improvement, decline, and death, but they were more likely to have stable high functioning. IMPLICATIONS: The results suggest that the affordable ALH milieu enabled low-income residents to maintain function or cope well with functional decline. The comparison with community-dwelling participants provides evidence that the affordable ALH milieu was comparatively beneficial.

Patterns of body weight in middle-aged and older Americans, by gender and race, 1993-2000.

OBJECTIVES: Despite evidence of poor health outcomes associated with excessive weight gain or loss, longitudinal patterns of body weight over the adult life course have not been fully described. This article seeks to address this by examining body weight patterns for middle-aged and older adults. METHODS: Panel data from the Health and Retirement Study (HRS) original cohort and the original cohort of the Asset and Health Dynamics Among the Oldest Old (AHEAD) study are used to compare, by social group, characteristics of respondents and non-respondents, baseline weight (1993 and 1994) to year 2000 weight, and explore various weight change trajectories over time. RESULTS: Overall, a greater proportion of middle-aged adults are heavier over time than at baseline and a greater proportion of older adults lose weight over time compared to baseline. Examining the transitions across weight trajectories for all of the social groups suggests considerable variability. CONCLUSIONS: These findings suggest that differing physiologic and social or environmental experiences may have implications for body weight patterns. Understanding these patterns by race/ethnicity and gender could provide insight into health disparities among different social groups.