Early Patient-Centered Outcomes Research Experience With the Use of Telehealth to Address Disparities: Scoping Review.

BACKGROUND: Health systems and providers across America are increasingly employing telehealth technologies to better serve medically underserved low-income, minority, and rural populations at the highest risk for health disparities. The Patient-Centered Outcomes Research Institute (PCORI) has invested US $386 million in comparative effectiveness research in telehealth, yet little is known about the key early lessons garnered from this research regarding the best practices in using telehealth to address disparities. OBJECTIVE: This paper describes preliminary lessons from the body of research using study findings and case studies drawn from PCORI seminal patient-centered outcomes research (PCOR) initiatives. The primary purpose was to identify common barriers and facilitators to implementing telehealth technologies in populations at risk for disparities. METHODS: A systematic scoping review of telehealth studies addressing disparities was performed. It was guided by the Arksey and O'Malley Scoping Review Framework and focused on PCORI's active portfolio of telehealth studies and key PCOR identified by study investigators. We drew on this broad literature using illustrative examples from early PCOR experience and published literature to assess barriers and facilitators to implementing telehealth in populations at risk for disparities, using the active implementation framework to extract data. Major themes regarding how telehealth interventions can overcome barriers to telehealth adoption and implementation were identified through this review using an iterative Delphi process to achieve consensus among the PCORI investigators participating in the study. RESULTS: PCORI has funded 89 comparative effectiveness studies in telehealth, of which 41 assessed the use of telehealth to improve outcomes for populations at risk for health disparities. These 41 studies employed various overlapping modalities including mobile devices (29/41, 71%), web-based interventions (30/41, 73%), real-time videoconferencing (15/41, 37%), remote patient monitoring (8/41, 20%), and store-and-forward (ie, asynchronous electronic transmission) interventions (4/41, 10%). The studies targeted one or more of PCORI's priority populations, including racial and ethnic minorities (31/41, 41%), people living in rural areas, and those with low income/low socioeconomic status, low health literacy, or disabilities. Major themes identified across these studies included the importance of patient-centered design, cultural tailoring of telehealth solutions, delivering telehealth through trusted intermediaries, partnering with payers to expand telehealth reimbursement, and ensuring confidential sharing of private information. CONCLUSIONS: Early PCOR evidence suggests that the most effective health system- and provider-level telehealth implementation solutions to address disparities employ patient-centered and culturally tailored telehealth solutions whose development is actively guided by the patients themselves to meet the needs of specific communities and populations. Further, this evidence shows that the best practices in telehealth implementation include delivery of telehealth through trusted intermediaries, close partnership with payers to facilitate reimbursement and sustainability, and safeguards to ensure patient-guided confidential sharing of personal health information.

Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials.

Informed consent is essential to ethical research and is requisite to participation in clinical research. Yet most hematopoietic cell transplantation (HCT) informed consent forms (ICFs) are written at reading levels that are above the ability of the average person in the United States (U.S.). The recent development of ICF templates by the National Cancer Institute, National Institutes of Health, and the National Heart Blood and Lung Institute have not resulted in increased patient comprehension of information. Barriers to creating Easy-to-Read ICFs that meet U.S. federal requirements and pass institutional review board (IRB) review are the result of multiple interconnected factors. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) formed an ad hoc review team to address concerns regarding the overall readability and length of ICFs used for BMT CTN trials. This paper summarizes recommendations of the review team for the development and formatting of Easy-to-Read ICFs for HCT multicenter clinical trials, the most novel of which is the use of a 2-column format. These recommendations intend to guide the ICF writing process, simplify local IRB review of the ICF, enhance patient comprehension, and improve patient satisfaction. The BMT CTN plans to evaluate the impact of the Easy-to-Read format compared with the traditional format on the informed consent process.

Open-loop feedback increases physical activity of youth.

PURPOSE: The number of youth that meet activity guidelines is decreasing and easy access to reinforcing sedentary behaviors competes with increasing physical activity. In the laboratory, open-loop feedback that used pedometer activity counts to gain access to sedentary alternatives doubled physical activity. This study evaluated the influence of open-loop feedback and reinforcement on physical activity and television (TV) time in a small clinical trial. METHODS: Children (8-12 yr old) were randomized to an open-loop feedback plus reinforcement intervention (N = 11) or no feedback, no reinforcement control (N = 7). Subjects wore an accelerometer for 6 wk and attended meetings to download the accelerometer. Accumulating physical activity counts gave subjects in the open-loop group access to TV time, controlled by a TV Allowance device, with 400 counts = 1 h of TV. The control group had no feedback for activity and free access to TV. RESULTS: The open-loop group had a 24% increase in physical activity, which was greater (P = 0.02) than the control group. TV time of the open-loop group was reduced by 18% or 20 min x d(-1) whereas the control group increased by 13 min x d(-1), but these were not significant changes. The change in time spent watching television was directly related to the change in BMI z-score (r = 0.69, P = 0.002). CONCLUSION: Open-loop feedback increases physical activity in children, thus helping children to achieve physical activity recommendations. Reductions in TV watching may reduce or minimize gains in body weight.

Relationship of leptin to bone mineralization in children and adolescents.

Serum leptin concentrations and bone mass are concordant in several respects. Obesity is associated with increased serum leptin concentrations and bone mineral, whereas undernutrition reduces serum leptin concentrations and bone mineral. Furthermore, both bone mineral and serum leptin concentrations increase at the initiation of puberty. However, there is a lack of empirical evidence of an independent association of serum leptin concentrations and bone mineral in youth. Thus, we used hierarchical regression to determine whether serum leptin concentrations were related to bone mineral in boys (n = 28) and girls (n = 31). Bone mineral content, density, and apparent density of the total body and body regions were measured by dual-energy x-ray absorptiometry and statistically adjusted for chronological age, fat mass, bone-free fat-free mass, and serum IGF-I and estradiol concentrations. Sequential addition of serum log((10)) leptin concentrations to the block of body size variables and the block of hormone variables did not increase R(2) for any of the total or regional bone mineral content, bone mineral density, and bone mineral apparent density variables. We conclude that serum leptin concentrations do not add to the prediction of bone mineral in youth after accounting for age, fat mass, bone-free fat-free mass, and serum IGF-I and estradiol concentrations.