Roger B. Davis

Reduced sodium meal plans are recommended by the Centers of Disease Control to lower blood pressure in older adults; however, this strategy has not been tested in a clinical trial. The Satter House Trial of Reduced Sodium Meals (SOTRUE) was an individual-level, double-blind, randomized controlled pilot study of adults living in a congregate living facility subsidized by the Federal Department of Housing and Urban Development (HUD). Adults over age 60 years ate 3 isocaloric meals with two snacks daily for 14 days. The meal plans differed in sodium density (2 mg/kcal), but were equivalent in potassium and macronutrients. Seated systolic BP (SBP) was the primary outcome, while urine sodium-creatinine ratio was used to measure compliance. Twenty participants were randomized (95% women; 95% white; mean age 78 ± 8 years), beginning in 7 October 2019. Retention was 100% with the last participant ending 4 November 2019. Mean baseline SBP changed from 121 to 116 mmHg with the typical sodium diet (−5 mmHg; 95% CI: −18, 8) and from 123 to 112 mmHg with the low sodium diet (−11 mmHg; 95% CI: −15.2, −7.7). Compared to the typical sodium meal plan, the low sodium meal plan lowered SBP by 4.8 mmHg (95% CI: −14.4, 4.9; p = 0.31) and urine sodium-creatinine ratio by 36% (−36.0; 95% CI: −60.3, 3.4; p = 0.07), both non-significant. SOTRUE demonstrates the feasibility of sodium reduction in federally mandated meal plans. A longer and larger study is needed to establish the efficacy and safety of low sodium meals in older adults.

Ideal cardiovascular health is associated with a decrease in adverse cardiovascular events. The My Research Legacy study examined ideal cardiovascular health using the Life’s Simple 7 survey and data from digital health devices. We hypothesized that digital devices provide a more objective view of overall cardiovascular health status than self-reported measures. Therefore, we analyzed weight and activity data recorded by digital devices to recalculate the Life’s Simple 7 Health Score. All study participants (n = 1561) answered the survey, while a subgroup (n = 390) provided data from digital devices. Individuals with digital devices had a lower body mass index (BMI) and higher weekly minutes of vigorous exercise than participants without digital devices (p < 0.01). Baseline Health Scores were higher in individuals with digital devices compared to those without (7.0 ± 1.6 vs. 6.6 ± 1.6, p < 0.01). Data from digital devices reveal both increases and decreases in measured vs. self-reported BMI (p < 0.04) and weekly minutes of moderate and vigorous exercise activity (p < 0.01). Using these data, a significant difference was found between the recalculated and the self-reported Life’s Simple 7 Health Score (p < 0.05). These findings suggest that incorporation of digital health devices should be considered as part of a precision medicinal approach to assessing ideal cardiovascular health.

Longevity creates increasing care needs for healthcare providers and family caregivers. Increasingly, the burden of care falls to one primary caregiver, increasing stress and reducing health outcomes. Additionally, little has been published on adults’, over the age of 75, preferences in the development of health information sharing with family members using online platforms. This study aims to assess a novel, Internet based, family-centric communication and collaboration platform created to address the information needs of elders and their informal caregivers in a community setting. This study is an internet-based, open prospective cohort study, enrolling dyad pairs of one adult over the age of 75 with one informal caregiver. Dyads will be offered to use the InfoSAGE online platform without prospective assignment. Participants will consent using an online process that enables participation from any location and shares important study and privacy details. The platform will enable the capture of search queries and tracking of functions such as tasks and discussions. Surveys every six months assess health status, health and social needs, and caregiver burden using validated instruments over a two-year period. We will use a mixed methods approach, utilizing qualitative survey data along with website usage analytic data. Analysis of the longitudinal usage and survey data will help to examine the patterns of family communication and health information seeking as the central older adult ages. We will use the study data to inform design recommendations relevant to a complex mixture of users, with special consideration to the needs of older adult users and potential physical limitations.

Volume overload poses a major risk in hemodialysis patients but simple detection methods are lacking. We propose a novel marker, the Interdialytic Creatinine Rise (IDCR), readily calculated as the change in serum creatinine over time (in mg/dL/h), to assess volume overload and predict mortality risk in hemodialysis patients. First, we calculated IDCR changes with volume in a prospective cohort of 35 hospitalized hemodialysis patients awaiting hemodialysis and 33 hospitalized patients undergoing hemodialysis every other day. Second, in a prospective cohort of 25 outpatients, IDCR cutoff values associated with hypervolemia were determined between two treatments and compared with simultaneous volume assessments by their nephrologist. Third, IDCR as a mortality predictor was studied using survival analysis in a longitudinal retrospective cohort study of 39 maintenance hemodialysis patients followed from 2012 until death or 2017. IDCR decreased by − 0.014 mg/dL/h each day (95%CI − 0.017,− 0.010; p < 0.001) without dialysis due to fluid volume gain and increased by 0.013 mg/dL/h (95%CI 0.008,0.017; p < 0.001) from before to after each successive hemodialysis due to fluid removal. Choosing an IDCR cutoff value of ≤0.1 had sensitivity of 82% and specificity of 79% in diagnosing volume overload with the area under the ROC curve of 0.78 (95%CI 0.59,0.97). The hazard ratio of death for each 0.01 decrease in IDCR was 1.64 (95%CI 1.31,2.07; p < 0.001). If IDCR decreased to less than 0.05 mg/dL/h, the median survival was 32 days and the odds ratio of death within 2 months was 38 (95%CI 8, 131; p < 0.001). In this pilot study, IDCR is shown to be a novel metric that decreases with fluid retention and increases after fluid removal. IDCR can assist clinicians in detection or exclusion of volume overload in hemodialysis patients and provide prognostic value in identifying those at high risk for death.

Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment. This paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants’ experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup. OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the “culture” of the trial as well as potential mechanisms of OLP and ethical implications. ClinicalTrials.gov, identifier: NCT02802241 . Registered on 14 June 2016.

Adults with mood disorders frequently use prescription opioids. The factors associated with this increased use remain unclear. We used the Medical Expenditure Panel Surveys from 2005 to 2011 to measure the association of mood disorders with new opioid use and the transition to longer-term opioid use for a variety of pain conditions before and after controlling for patient characteristics and clinical disability. We analyzed 33,450 adults with likely acute or potentially chronic pain conditions who were not using opioids at baseline.Among respondents with likely acute pain conditions, those with mood disorders initiated opioids more frequently for that pain condition compared with those without mood disorders (19.3%, vs 17.2%,P= 0.01). After initiation, they also transitioned to longer-term opioid therapy more frequently (11.7% vs 5.3%,P< 0.01). Among respondents with potentially chronic pain conditions, adults with mood disorders initiated opioid therapy more frequently for their chronic pain condition (11.5% vs 9.2%,P< 0.01) and transitioned to longer-term therapy more frequently (36.8% vs 19.9%,P< 0.01). After adjusting for sociodemographics and clinical disability, there was no association between mood disorders and new opioid use for likely acute (adjusted odds ratio [aOR] 1.05 [0.92-1.20]) or potentially chronic pain (aOR 0.91 [0.80-1.03]). However, there remained a strong association between mood disorders and the transition to longer-term opioid use for likely acute (aOR 1.77 [1.15-2.72]) and potentially chronic pain (aOR 1.95 [1.42-2.68]). Targeting the transition to longer-term opioid use may help clinicians reduce potentially inappropriate opioid prescriptions in this high-risk population.

Obstet Gynecol Surv 2016;71(2):57–58 In response to a high rate of unplanned pregnancies, public health initiatives have focused on the importance of preconception health counseling for women of childbearing age who may become pregnant, either intentionally or unintentionally. Nearly half of women in this age group have used some type of complementary and alternative medicine (CAM).