From pilot data to clinical trial: observing the effects of vitamin D dosage on bone quality

INTRODUCTION The relationship between vitamin D and bone quality has been widely researched. Vitamin D is an essential component of normal bone health as well as calcium/phosphate metabolism. Despite significant research efforts, the optimum level of vitamin D intake remains a topic of controversy amongst industry experts. For example, the Institute of Medicine recommends between 600 and 800 international units (IU) per day [1,2]. In contrast, both the osteoporosis Canada and the Endocrine Society guidelines recommend a higher daily dosage of 400 to 2000 IU [3,4]. To date, there have been no studies assessing dose-related vitamin D intake and bone health. The absence of research in this area was the major motivation for both the pilot study and clinical trial presented in this abstract. METHODS: PILOT DATA Participants included in this study were patients from the Pure North S’Energy Foundation (PNSF). All participants received a series of blood draws from PNSF, which determined the vitamin D levels in their blood. These levels were then used to divide participants into four different groups: low vitamin D (<90 mmol/L), normal vitamin D (>90 mmol/L, <175 mmol/L), one time high vitamin D (>175 mmol/L for <6 months), and high vitamin D (>175 mmol/L for >6 months). Participants were then scanned using high resolution peripheral quantitative computed tomography (HR-pQCT, Scanco Medical), to analyze their bone micro-architecture in both the non-dominant tibia and radius. SPSS (version 21) was used to analyze the differences between groups with a One-Way ANOVA and a Tukey Post-Hoc test. Significance was set at p<0.05. RESULTS: PILOT DATA Overall, 113 participants were scanned using HR-pQCT while only 105 were included in the final analysis. Participants were on average 56 years old and 62% female. Both vitamin D (p<0.01) and calcium (p<0.05) were statistically significant between groups using a One-Way ANOVA. At the radius, cortical thickness (p<0.05) and cortical area (p<0.05) were statistically significant across groups. Results from the Tukey Post-Hoc test showed that cortical thickness was significantly lower for low vitamin D compared to the high vitamin D group, as well as lower for the one-time high compared to the high vitamin D group. For cortical area, the one-time high group was significantly lower than the high vitamin D group. For the tibia, trabecular thickness was the only significant variable across groups (p<0.05), with low vitamin D being lower than the one time high vitamin D.   CONCLUSIONS: PILOT DATA There were some bone parameters that were statistically different between vitamin D groups. Of these statistically significant parameters, results differed between the radius and the tibia, as well as between cortical and trabecular bone. Most variables differed between the one-time high group and either the low or high groups. The only difference between the low and high groups was cortical thickness. This pilot data shows some interesting results, and the need for further, more controlled studies. FUTURE WORK: CLINICAL TRIAL This project will move forward in the form of a clinical trial entitled “A randomized double-blind study investigating dose-dependent longitudinal effects of vitamin D supplementation on bone health”. The study will include approximately 300 healthy men and women between the ages of 55-70 years. Similar to the pilot study, participants will be assigned to one of three vitamin D dosages and HR-pQCT will be used to assess bone quality. Other methods such as Dual X-ray Absorptiometry and health questionnaires will also be used to assess overall skeletal, physical and mental health

Cost-Benefit Analysis of the COPE Program for Persons Living With Dementia: Toward a Payment Model

Background and objectives: There is a critical need for effective interventions to support quality of life for persons living with dementia and their caregivers. Growing evidence supports nonpharmacologic programs that provide care management, disease education, skills training, and support. This cost-benefit analysis examined whether the Care of Persons with Dementia in their Environments (COPE) program achieves cost savings when incorporated into Connecticut\u27s home- and community-based services (HCBS), which are state- and Medicaid-funded. Research design and methods: Findings are based on a pragmatic trial where persons living with dementia and their caregiver dyads were randomly assigned to COPE with HCBS, or HCBS alone. Cost measures included those relevant to HCBS decision makers: intervention delivery, health care utilization, caregiver time, formal care, and social services. Data sources included care management records and caregiver report. Results: Per-dyad mean cost savings at 12 months were $2 354 for those who received COPE with a mean difference-in-difference of -$6 667 versus HCBS alone (95% CI: -$15 473,$2 734; not statistically significant). COPE costs would consume 5.6%-11.3% of Connecticut\u27s HCBS annual spending limit, and HCBS cost-sharing requirements align with participants\u27 willingness to pay for COPE. Discussion and implications: COPE represents a potentially cost-saving dementia care service that could be financed through existing Connecticut HCBS. HCBS programs represent an important, sustainable payment model for delivering nonpharmacological dementia interventions such as COPE

An Economic Evaluation of a Novel Electronic Discharge Communication Tool

The transition from acute-care hospitalization to community-based care is a vulnerable period in healthcare delivery due to potential for post-discharge adverse events. This vulnerability has been attributed to the miscommunication between acute and community-based physicians, as current systems do not control for legibility, completeness or timeliness of the discharge summary. One potential approach to bridging this communication gap is the use of electronic discharge communication tools, which can be designed to ensure the consistent and timely transfer of information. Given the limited healthcare budget, the costs and benefits of these tools should be considered prior to large scale implementation. Thus, the goal of this thesis is to establish the cost-effectiveness of electronic discharge communication tools. To achieve this, a systematic review of published literature was conducted (Chapter 2), a prospective economic evaluation of a novel electronic discharge communication tool was completed (Chapter 3), and policy options/considerations were presented (Chapter 4)

Palliative care in the home: a scoping review of study quality, primary outcomes, and thematic component analysis

Abstract Background The aim of palliative care is to improve the quality of life of patients and families through the prevention and relief of suffering. Frequently, patients may choose to receive palliative care in the home. The objective of this paper is to summarize the quality and primary outcomes measured within the palliative care in the home literature. This will synthesize the current state of the literature and inform future work. Methods A scoping review was completed using PRISMA guidelines. PubMed, Embase, CINAHL, Web of Science, Cochrane Library, EconLit, PsycINFO, Centre for Reviews and Dissemination, Database of Abstracts of Reviews of Effects, and National Health Service Economic Evaluation Database were searched from inception to August 2016. Inclusion criteria included: 1) care was provided in the “home of the patient” as defined by the study, 2) outcomes were reported, and 3) reported original data. Thematic component analysis was completed to categorize interventions. Results Fifty-three studies formed the final data set. The literature varied extensively. Five themes were identified: accessibility of healthcare, caregiver support, individualized patient centered care, multidisciplinary care provision, and quality improvement. Primary outcomes were resource use, symptom burden, quality of life, satisfaction, caregiver distress, place of death, cost analysis, or described experiences. The majority of studies were of moderate or unclear quality. Conclusions There is robust literature of varying quality, assessing different components of palliative care in the home interventions, and measuring different outcomes. To be meaningful to patients, these interventions need to be consistently evaluated with outcomes that matter to patients. Future research could focus on reaching a consensus for outcomes to evaluate palliative care in the home interventions

Additional file 1: of Palliative care in the home: a scoping review of study quality, primary outcomes, and thematic component analysis

Appendix 1. PubMed search strategy. (DOCX 15 kb

Additional file 2: of Palliative care in the home: a scoping review of study quality, primary outcomes, and thematic component analysis

Table S1. Included study characteristics. (DOCX 48 kb