D-CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System-Based Versus Community-Based Dementia Care Versus Usual Dementia Care.

BACKGROUND/OBJECTIVES: Although several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost effectiveness of community-based dementia care (CBDC) versus health system-based dementia care (CBDC) and the effectiveness of both approaches compared with usual care (UC) are unknown. DESIGN: Pragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad. SETTING: Four clinical trial sites (CTSs) based in academic and clinical health systems. PARTICIPANTS: A total of 2,150 English- or Spanish-speaking PWD who are not receiving hospice or residing in a nursing home and their caregivers. INTERVENTIONS: Eighteen months of (1) HSDC provided by a nurse practitioner or physician's assistant dementia care specialist who works within the health system, or (2) CBDC provided by a social worker or nurse care consultant who works at a community-based organization, or (3) UC with as needed referral to the Alzheimer's Association Helpline. MEASUREMENTS: Primary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales. SECONDARY OUTCOMES: NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, "time spent at home," Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost effectiveness using intervention costs and Medicare claims. RESULTS: The results will be reported in the spring of 2024. CONCLUSION: D-CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared with UC and will evaluate the cost effectiveness of each intervention.

Tricyclic Antidepressant and/or γ-Aminobutyric Acid-Analog Use Is Associated With Fall Risk in Diabetic Peripheral Neuropathy.

BACKGROUND/OBJECTIVES: Peripheral neuropathy is a common diabetes complication that can increase fall risk. Regarding fall risk, the impact of pain management using tricyclic antidepressants (TCAs) or γ-aminobutyric acid (GABA) analogs is unclear because these medications can also cause falls. This study investigates the impact of these drugs on fall and fracture risk in older diabetic peripheral neuropathy (DPN) patients. DESIGN: Historical cohort study with 1-to-1 propensity matching of TCA/GABA-analog users and nonusers. SETTING: Nationally representative 5% Medicare sample between the years 2008 and 2010. PARTICIPANTS: After applying all selection criteria, 5,550 patients with prescription and 22,200 patients without prescription of TCAs/GABA-analogs were identified. Both patient groups were then stratified for fall history and matched based on propensity of receiving TCAs/GABA-analogs within each group. MEASUREMENTS: Patients were followed until the first incidence of fall or the first incidence of fracture during the follow-up period (for up to 5 years). RESULTS: After matching, users and nonusers were largely similar. After covariate adjustment, TCA/GABA-analog use was associated with a statistically significant increase in fall risk (adjusted hazard ratio [HR] = 1.11; 95% confidence interval [CI] = 1.03-1.20), but was not associated with fracture risk (adjusted HR = 1.09; 95% CI = 0.99-1.19) in the conventional analysis. Treating TCA/GABA-analog use as a time-dependent covariate resulted in statistically significant associations of TCA/GABA-analog use with both fall and fracture risk (HR = 1.26 [95% CI = 1.17-1.36]; and HR = 1.12 [95% CI = 1.02-1.24], respectively). CONCLUSION: Among older patients with DPN, GABA-analogs or TCAs increase fall risk and possibly fracture risk. Use of these medications is therefore a potentially modifiable risk factor for falls and fractures in this population.

Androgen Therapy and Rehospitalization in Older Men With Testosterone Deficiency.

OBJECTIVE: To assess whether the receipt of androgen therapy is associated with a reduced 30-day rehospitalization rate among older men with testosterone deficiency. PATIENTS AND METHODS: We conducted a retrospective cohort study using a 5% national sample of Medicare beneficiaries. We identified 6372 nonsurgical hospitalizations between January 1, 2007, and December 31, 2012, for male patients aged 66 years and older with a previous diagnosis of testosterone deficiency. Patients who died or lost Medicare coverage in the 30 days after hospital discharge or who were discharged to another inpatient setting were excluded from the analysis. Logistic regression was used to calculate odds ratios (ORs) and 95% CIs for the risk of 30-day hospital readmissions associated with receipt of androgen therapy. RESULTS: In older men with testosterone deficiency, receipt of androgen therapy was associated with a reduced risk of rehospitalization (91 of 929 androgen users [9.8%] vs 708 of 5443 non-androgen users [13.0%]; OR, 0.73; 95% CI, 0.58-0.92) in the 30 days after hospital discharge. In a logistic regression analysis adjusting for multiple demographic, clinical, and health service variables, the OR was similar (OR, 0.75; 95% CI, 0.59-0.95). The adjusted OR for unplanned 30-day hospital readmissions was 0.62 (95% CI, 0.47-0.83). Each of these findings persisted across a range of propensity score analyses-including adjustment, stratification, and inverse probability treatment weighting-and several sensitivity analyses. CONCLUSION: Androgen therapy may reduce the risk of rehospitalization in older men with testosterone deficiency. Given the high rates of early hospital readmission among older adults, further exploration of this intervention holds broad clinical and public health relevance.

Kyphoplasty for vertebral augmentation in the elderly with osteoporotic vertebral compression fractures: scenarios and review of recent studies.

BACKGROUND: Vertebral compression fractures caused by osteoporosis are among the most common fractures in the elderly. The treatment focuses on pain control, maintenance of independence, and management of the osteoporosis. Elderly patients often encounter adverse effects to pain medications, do not tolerate bed rest, and are not ideal candidates for invasive spinal reconstructive surgery. Percutaneous vertebral augmentation (vertebroplasty or kyphoplasty) has become popular as a less-invasive alternative. However, studies have questioned the effectiveness of these procedures. METHODS: The authors conducted a MEDLINE search using relevant search terms including osteoporosis, osteoporotic vertebral compression fracture, elderly, kyphoplasty and vertebroplasty. CASE SUMMARY/RESULTS: Two elderly patients presented with a fracture of their third and first lumbar vertebral body, respectively. One patient progressed well with conservative treatment, whereas the other patient was hospitalized secondary to pain after conservative measures failed to offer improvement. The hospitalized patient subsequently opted for a kyphoplasty and was able to resume his normal daily activities after the procedure. CONCLUSIONS: Selecting patients on an individual case-by-case basis can optimize the effectiveness and outcomes of a vertebral augmentation. This process includes the documentation of an osteoporotic vertebral compression fracture with the aide of imaging studies, including the acuity of the fracture as well as the correlation with the physical examination findings. Patients who are functional and improving under a conservative regimen are not candidates for kyphoplasty. However, if the conservative management is not successful after 4 to 6 weeks and the patient is at risk to become bedridden, an augmentation should be considered. A kyphoplasty procedure may be preferred over vertebroplasty, given the lower risk profile and better outcomes regarding spinal alignment.

Protein metabolism in women and men: similarities and disparities.

PURPOSE OF REVIEW: To provide an objective and comprehensive review of the recent literature addressing the effects of sex on protein metabolism. We also evaluate whether these differences can be attributed to physiology or methodology. Because of the developmental changes in hormonal milieu and body composition that occur across life, the literature has been examined in a longitudinal manner across the lifespan. RECENT FINDINGS: Throughout most points of life, men and women of similar health status and BMI display fairly similar protein turnover rates. However, some investigators have reported sexual dimorphism in protein metabolism, which may be partly attributable to differences in fat-free mass and/or methodology. In periods of significant changes in the hormonal milieu (puberty and menopause), sex differences may become more evident. Finally, anabolic stimuli such as feeding and exercise may help highlight any discrepancies in protein turnover between men and women. SUMMARY: Sex differences in protein metabolism, if any, are most evident during the main phases of hormonal changes, and may be also due to differences in body composition. However, methodological issues and sample size must be considered when designing and evaluating these studies.