Dietary Inflammatory Potential and Bone Outcomes in Midwestern Post-Menopausal Women.

Little is known about the inflammatory potential of diet and its relation to bone health. This cross-sectional study examined the association between the inflammatory potential of diet and bone-related outcomes in midwestern, post-menopausal women enrolled in the Heartland Osteoporosis Prevention Study (HOPS) randomized controlled trial. Dietary intake from the HOPS cohort was used to calculate Dietary Inflammatory Index (DII®) scores, which were energy-adjusted (E-DIITM) and analyzed by quartile. The association between E-DII and lumbar and hip bone mineral density (BMD) and lumbar trabecular bone scores (TBS; bone structure) was assessed using ANCOVA, with pairwise comparison to adjust for relevant confounders (age, education, race/ethnicity, smoking history, family history of osteoporosis/osteopenia, BMI, physical activity, and calcium intake). The cohort included 272 women, who were predominately white (89%), educated (78% with college degree or higher), with a mean BMI of 27 kg/m2, age of 55 years, and E-DII score of -2.0 ± 1.9 (more anti-inflammatory). After adjustment, E-DII score was not significantly associated with lumbar spine BMD (p = 0.53), hip BMD (p = 0.29), or TBS at any lumbar location (p > 0.05). Future studies should examine the longitudinal impact of E-DII scores and bone health in larger, more diverse cohorts.

Bone-loading exercises versus risedronate for the prevention of osteoporosis in postmenopausal women with low bone mass: a randomized controlled trial.

PURPOSE: This randomized controlled trial compared changes in bone mineral density (BMD) and bone turnover in postmenopausal women with low bone mass randomized to 12 months of either risedronate, exercise, or a control group. METHODS: Two hundred seventy-six women with low bone mass, within 6 years of menopause, were included in analysis. Treatment groups were 12 months of (a) calcium and vitamin D supplements (CaD) (control), (b) risedronate + CaD (risedronate), or (c) bone-loading exercises + CaD (exercise). BMD and serum markers for bone formation (Alkphase B) and resorption (Serum Ntx) were analyzed at baseline, 6, and 12 months. RESULTS: Using hierarchical linear modeling, a group by time interaction was found for BMD at the spine, indicating a greater improvement in the risedronate group compared to exercise (p ≤ .010) or control groups (p ≤ .001). At 12 months, for women prescribed risedronate, changes in BMD at the spine, hip, and femoral neck from baseline were + 1.9%, + 0.9%, and + .09%; in exercise group women, + 0.2%, + 0.5%, and - 0.4%; and in control group women, - 0.7%, + 0.5%, and - 0.5%. There were also significant differences in reductions in Alkphase B (RvsE, p < .001, RvsC, p < .001) and Serum Ntx (RvsE, p = .004, RvsC, p = .007) in risedronate women compared to exercise and control groups. For risedronate, 12-month changes in Alkphase B and Serum Ntx were - 20.3% and - 19.0%; for exercise, - 6.7% and - 7.0%; and for control, - 6.3% and - 9.0%. CONCLUSION: Postmenopausal women with low bone mass should obtain adequate calcium and vitamin D and participate in bone-loading exercises. Additional use of BPs will increase BMD, especially at the spine.

Protocol for a pilot randomised controlled trial of zoledronic acid to prevent bone loss following sleeve gastrectomy surgery.

INTRODUCTION: Sleeve gastrectomy (SG) is an increasingly used and effective treatment for obesity; however, the rapid weight loss associated with SG adversely affects bone metabolism predisposing patients to skeletal fragility. Bisphosphonate medications have been evaluated for safety and efficacy in combating bone loss in patients with osteoporosis, but their use in SG-induced bone loss is limited. The goal of this study is to investigate how a one-time infusion of zoledronic acid compares to placebo, in its ability to combat SG-associated bone loss. METHODS AND ANALYSIS: This research protocol is a 9-month, pilot randomized controlled trial (RCT) involving 30 adult SG patients randomised to receive an infusion of either 5 mg of zoledronic acid or placebo, 6 weeks following surgery. To be included participants must be <350 lbs/158.8 kg, free of bone-impacting pathologies or medications, and must have adequate serum calcium and vitamin D levels at baseline. The primary outcome is change in areal bone mineral density (aBMD) at the total hip. Secondary outcomes include change in aBMD of the femoral neck, and lumbar spine, and change in volumetric BMD at the lumbar spine. The primary aim will be tested using a linear mixed model fit with total hip aBMD at 9 months as the outcome. Treatment, participant sex and menopausal status will be considered in analysis. Groups will be compared using contrast statements at 9 months, with change over 9 months being the primary comparison. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Board of the University of Nebraska Medical Center (IRB820-19). Written consent will be obtained from participants at enrolment by trained staff. Careful and thorough explanation are used in obtainment of consent and voluntariness is emphasised throughout the trial. The findings of this study will be presented locally, nationally, and published in peer-reviewed journals. Additional details will be reported on ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT04279392.

Promoting adherence to bone-loading exercises in postmenopausal women with low bone mass.

BACKGROUND: We recently completed a parent study (Bone Loading Exercises versus Risedronate on Bone Health in Post-menopausal Women [NIH# R01NR015029]) examining bone-loading exercises to prevent bone loss in postmenopausal women with low bone mass. Forty-three million US women have low bone mass and increased risk for fractures. Bone-loading exercises (weight-bearing and resistance training) can preserve bone mass and decrease risk of fractures. However, multiple barriers prevent women from exercising and adherence rates are low. PURPOSE: This secondary analysis of the parent study (a) examined barriers specific to women participating in bone-loading exercises; (b) described effectiveness of self-efficacy strategies used in the parent study for increasing confidence in knowledge and reducing barriers; and (c) applied study findings and principles of self-efficacy and self-regulation in development of guidelines for promoting adherence to exercises. METHODS: Seventy-two women were randomized to the exercise group and completed 12 months of exercises. Instruments for self-efficacy were completed at 2 weeks and barriers interference at 6 months. Percent adherence was measured as the number of exercise sessions attended divided by the number prescribed. RESULTS: In the 12-month study, average adherence to exercises was 58.9%. Lower adherers reported lack of self-regulation skills such as "lack of time" as the most frequent barriers to exercise. IMPLICATIONS FOR PRACTICE: Guidelines developed included promotion of skills for self-regulation (such as regulation of time) as well as self-efficacy to improve adherence rates. Nurse practitioners may be the most motivated of all providers to use guidelines promoting exercise for women in their clinical practice.

Approaches to Recruitment of Postmenopausal Women for a Community-Based Study.

BACKGROUND: Few researchers have focused on the challenges of recruiting postmenopausal women for community-based research. Researchers have reported that multiple methods may be needed to recruit the required number of subjects. One contemporary approach to recruitment is use of Facebook. More studies are needed examining Facebook as a recruitment strategy. OBJECTIVE: The aim of the study was to examine which recruitment methods were most successful and cost-effective in recruiting postmenopausal women for a randomized controlled trial on bone loss. METHODS: Subjects were 276 postmenopausal women who had osteopenia and were within 5 years of menopause. Multiple methods were used to recruit women. To determine which methods were successful, women were asked how they learned about the study. Descriptive data were used to examine recruitment numbers as well as to determine the cost-effectiveness and enrollment efficiency of recruitment methods. RESULTS: Healthcare provider letters yielded the highest number of enrolled subjects (n = 58), followed by postcard mailings (n = 47), and Facebook posts (n = 44). Eleven subjects were referred by family and friends, five subjects were from newspaper or television, and two were from digital ads. Cost of recruitment per subject enrolled was highest with digital ads and postcard mailings. DISCUSSION: Recruitment could be more costly and time-consuming than anticipated. Recruitment using direct-targeted mailings, such as provider letters and postcards, was successful in our study and has been effective in previous studies reviewed. Facebook was successful for recruitment in our study and may continue to be useful for recruitment in the future, as the number of women accessing Facebook continues to increase.

An altered spatiotemporal gait adjustment during a virtual obstacle crossing task in patients with diabetic peripheral neuropathy.

This study investigates spatiotemporal gait adjustments that occur while stepping over virtual obstacles during treadmill walking in people with/without diabetic peripheral neuropathy (DPN). Eleven adults with Type 2 diabetes mellitus, ten DPN, and 11 age-matched healthy adults (HTY) participated in this study. They stepped over forthcoming virtual obstacles during treadmill walking. Outcomes such as success rate, spatiotemporal gait characteristics during obstacle crossing, and correlations between these variables were evaluated. The results partially supported our hypotheses that when comparing with HTY and DM, people with DPN adopted a crossing strategy which decreased obstacle crossing success rate and maximal toe elevation, and increased stride time and stance time during virtual obstacle crossing. This might be due to the compromised somatosensory functions of their lower extremity which may increase the risk of falling. This study also found an inter-leg relationship which may be applied to future stepping or obstacle crossing training that incorporates both legs as a means for improving outcomes of the trailing leg during daily obstacle negotiation.

Using patient-reported outcome measures to deliver enhanced supportive care to people with lung cancer: feasibility and acceptability of a nurse-led consultation model.

PURPOSE: Developing new supportive/palliative care services for lung cancer should encompass effective ways to promptly identify and address patients' healthcare needs. We examined whether an in-clinic, nurse-led consultation model, which was driven by use of a patient-reported outcomes (PRO) measure, was feasible and acceptable in the identification of unmet needs in patients with lung cancer. METHODS: A two-part, repeated-measures, mixed-methods study was conducted. Part 1 employed literature reviews and stakeholder focus group interviews to inform selection of a population-appropriate needs assessment PRO measure. In Part 2, lung cancer nurse specialists (CNS) conducted three consecutive monthly consultations with patients. Recruitment/retention data, PRO data, and exit interview data were analysed. RESULTS: The Sheffield Profile for Assessment and Referral to Care was the PRO measure selected based on Part 1 data. Twenty patients (response rate: 26%) participated in Part 2; 13 (65%) participated in all three consultations/assessments. The PRO measure helped patients to structure their thinking and prompted them to discuss previously underreported and/or sensitive issues, including such topics as family concerns, or death and dying. Lung CNS highlighted how PRO-measures-driven consultations differed from previous ones, in that their scope was broadened to allow nurses to offer personalised care. Small-to-moderate reductions in all domains of need were noted over time. CONCLUSIONS: Nurse-led PRO-measures-driven consultations are acceptable and conditionally feasible to holistically identify and effectively manage patient needs in modern lung cancer care. PRO data should be systematically collected and audited to assist in the provision of supportive care to people with lung cancer.

Gestational Diabetes: Diagnosis, Classification, and Clinical Care.

Gestational diabetes mellitus (GDM) affects approximately 6% of pregnant women, and prevalence is increasing in parallel with the obesity epidemic. Protocols for screening/diagnosing GDM are controversial with several guidelines available. Treatment of GDM results in a reduction in the incidence of preeclampsia, shoulder dystocia, and macrosomia. If diet and lifestyle changes do not result in target glucose levels, then treatment with metformin, glyburide, or insulin should begin. It is generally recommended that pregnancies complicated by GDM do not go beyond term. For women identified to have prediabetes, intensive lifestyle intervention and metformin have been shown to prevent or delay progression to type 2 diabetes.

Protocol for a randomized controlled trial to compare bone-loading exercises with risedronate for preventing bone loss in osteopenic postmenopausal women.

BACKGROUND: In the United States, over 34 million American post-menopausal women have low bone mass (osteopenia) which increases their risk of osteoporosis and fractures. Calcium, vitamin D and exercise are recommended for prevention of osteoporosis, and bisphosphonates (BPs) are prescribed in women with osteoporosis. BPs may also be prescribed for women with low bone mass, but are more controversial due to the potential for adverse effects with long-term use. A bone loading exercise program (high-impact weight bearing and resistance training) promotes bone strength by preserving bone mineral density (BMD), improving bone structure, and by promoting bone formation at sites of mechanical stress. METHODS/DESIGN: The sample for this study will be 309 women with low bone mass who are within 5 years post-menopause. Subjects are stratified by exercise history (≥2 high intensity exercise sessions per week; < 2 sessions per week) and randomized to a control or one of two treatment groups: 1) calcium + vitamin D (CaD) alone (Control); 2) a BP plus CaD (Risedronate); or 3) a bone loading exercise program plus CaD (Exercise). After 12 months of treatment, changes in bone structure, BMD, and bone turnover will be compared in the 3 groups. Primary outcomes for the study are bone structure measures (Bone Strength Index [BSI] at the tibia and Hip Structural Analysis [HSA] scores). Secondary outcomes are BMD at the hip and spine and serum biomarkers of bone formation (alkaline phosphase, AlkphaseB) and resorption (Serum N-terminal telopeptide, NTx). Our central hypothesis is that improvements in bone strength will be greater in subjects randomized to the Exercise group compared to subjects in either Control or Risedronate groups. DISCUSSION: Our research aims to decrease the risk of osteoporotic fractures by improving bone strength in women with low bone mass (pre-osteoporotic) during their first 5 years' post-menopause, a time of rapid and significant bone loss. Results of this study could be used in developing a clinical management pathway for women with low bone mass at their peak period of bone loss that would involve lifestyle modifications such as exercises prior to medications such as BPs. TRIAL REGISTRATION: Clinicaltrials.gov NCT02186600 . Initial registration: 7/7/2014.

Prevalence and clinical significance of medication discrepancies at pediatric hospital admission.

OBJECTIVE: To quantify admission medication discrepancies in a tertiary-care, general pediatric population, to describe their clinical importance and associated factors, and to assess a screening approach to pharmacist involvement. METHODS: A total of 272 patients were studied prospectively at hospital admission. The study pharmacist performed a medication history and compared it to physicians' admission medication orders. Discrepancies between the 2 were coded as intentional but undocumented or unintentional. Unintentional discrepancies were rated for potential to cause harm by 3 physicians. Additional data collected included patients' reason for admission and presence of chronic conditions, whether physicians used a medication reconciliation form, the characteristics of patients' home medication regimen, and the time required to perform a pharmacist history and reconciliation. Interrater reliability and associations between baseline characteristics and discrepancy rates were explored. RESULTS: Eighty patients (30%) had at least one undocumented intentional discrepancy (range, 0-7). At least one unintentional discrepancy (range, 0-9) was found in 59 patients (22%). Of the unintentional discrepancies, 23% had moderate and 6% had severe potential to cause discomfort or deterioration. Ratings were similar among the 3 physicians. Characteristics associated with higher risk of clinically important discrepancies were: use of the medication reconciliation form, > or =4 prescription medications, and antiepileptic drug use. Logistic regression revealed that only the variable > or =4 medications was independently associated with clinically important discrepancies. CONCLUSIONS: Admission medication errors are common in this tertiary-care, general pediatric population, and nearly a third represent potential adverse events. The use of a medication reconciliation form by physicians without pharmacist involvement does not appear to reduce errors. A cutoff of > or =4 prescription medications is highly sensitive for identifying patients at risk of clinically important discrepancies.