Randomized study of induction with bendamustine-rituximab ± bortezomib and maintenance with rituximab ± lenalidomide for MCL.

Although initial therapy of mantle cell lymphoma (MCL) is not standardized, bendamustine plus rituximab (BR) is commonly used in older patients. Rituximab (R) maintenance after induction is often used. Thus, the open-label, randomized phase 2 ECOG-ACRIN Cancer Research Group E1411 trial was designed to test 2 questions: (1) does addition of bortezomib to BR induction (BVR) and/or (2) addition of lenalidomide to rituximab (LR) maintenance improve progression-free survival (PFS) in patients with treatment-naïve MCL? From 2012 to 2016, 373 previously untreated patients, 87% aged ≥60 years, were enrolled in this trial.

Cognitive Dysfunction: Feasibility of a Brief Intervention to Help Breast Cancer Survivors.

Background: Many cancer survivors experience cancer-related cognitive dysfunction (CRCD), which is believed to be the result of multiple contributing biologic, situational, and personal factors. Efficacious, clinically implementable interventions addressing the multifactorial nature of CRCD are needed.

Objectives: This study evaluated the feasibility of an intervention to help breast cancer survivors mitigate the effects of modifiable factors that contribute to CRCD and improve cognitive functioning.

Association of High-resolution Peripheral Quantitative Computed Tomography (HR-pQCT) bone microarchitectural parameters with previous clinical fracture in older men: The Osteoporotic Fractures in Men (MrOS) study.

High-resolution peripheral quantitative computed tomography (HR-pQCT) assesses both volumetric bone mineral density (vBMD) and trabecular and cortical microarchitecture. However, studies of the association of HR-pQCT parameters with fracture history have been small, predominantly limited to postmenopausal women, often performed limited adjustment for potential confounders including for BMD, and infrequently assessed strength or failure measures. We used data from the Osteoporotic Fractures in Men (MrOS) study, a prospective cohort study of community-dwelling men aged ≥65 years, to evaluate the association of distal radius, proximal (diaphyseal) tibia and distal tibia HR-pQCT parameters measured at the Year 14 (Y14) study visit with prior clinical fracture.

Association of Incident, Clinically Undiagnosed Radiographic Vertebral Fractures With Follow-Up Back Pain Symptoms in Older Men: the Osteoporotic Fractures in Men (MrOS) Study.

Prior data in women suggest that incident clinically undiagnosed radiographic vertebral fractures (VFs) often are symptomatic, but misclassification of incident clinical VF may have biased these estimates. There are no comparable data in men. To evaluate the association of incident clinically undiagnosed radiographic VF with back pain symptoms and associated activity limitations, we used data from the Osteoporotic Fractures in Men (MrOS) Study, a prospective cohort study of community-dwelling men aged ≥65 years.

Effect of initiating use of an insulin pump in adults with type 1 diabetes using multiple daily insulin injections and continuous glucose monitoring (DIAMOND): a multicentre, randomised controlled trial.

Background: The benefit of initiation of insulin pump therapy (continuous subcutaneous insulin infusion; CSII) in patients with type 1 diabetes using continuous glucose monitoring (CGM) has not been studied. We aimed to assess glycaemic outcomes when switching from multiple daily injections (MDI) to CSII in adults with type 1 diabetes using CGM.

Methods: In this multicentre, randomised controlled trial, 75 adults with type 1 diabetes in the CGM group of the DIAMOND trial were randomly assigned via the study website using a computer-generated sequence to continue MDI or switch to CSII, with continuation of CGM, for 28 weeks.

Implementation of Routine Postpartum Depression Screening and Care Initiation Across a Multispecialty Health Care Organization: An 18-Month Retrospective Analysis.

Objectives Postpartum depression (PPD) affects approximately 10-20% of all mothers after giving birth. Adequate screening and follow-up care for the postpartum mother with depression is an essential component of quality care in this population. The purpose of this quality improvement project was to evaluate the quality and quantity of a postnatal PPD screening program and the subsequent initiation of needed PPD treatment in an integrated health system.

Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial.

Importance: Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection.

Objective: To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections.

Design, Setting, And Participants: Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A1c (HbA1c) levels of 7.

Association of Increased Urinary Albumin With Risk of Incident Clinical Fracture and Rate of Hip Bone Loss: the Osteoporotic Fractures in Men Study.

Prior studies suggest that increased urine albumin is associated with a heightened fracture risk in women, but results in men are unclear. We used data from Osteoporotic Fractures in Men (MrOS), a prospective cohort study of community-dwelling men aged ≥65 years, to evaluate the association of increased urine albumin with subsequent fractures and annualized rate of hip bone loss. We calculated albumin/creatinine ratio (ACR) from urine collected at the 2003-2005 visit.

Slow Gait Speed and Risk of Long-Term Nursing Home Residence in Older Women, Adjusting for Competing Risk of Mortality: Results from the Study of Osteoporotic Fractures.

Objectives: To determine whether slow gait speed increases the risk of costly long-term nursing home residence when accounting for death as a competing risk remains unknown.

Design: Longitudinal cohort study using proportional hazards models to predict long-term nursing home residence and subdistribution models with death as a competing risk.

Setting: Community-based prospective cohort study.

Providing Breast Cancer Survivorship: Lessons Learned From a Pilot Project Implementation.

Background: Many cancer survivors have gaps in knowledge of their disease and treatments received.

Objective: The goal of this project was to evaluate the development and implementation of a pilot breast cancer survivorship program aimed at decreasing the gap in patient knowledge of disease and treatment, from both the staff and patient perspectives.

Methods: A mixed methods approach used data from multiple sources: (1) historical data, (2) medical record review, (3) a mailed patient questionnaire, (4) 1:1 semistructured telephone interviews with patients, and (5) 1:1 semistructured interviews with staff members.

Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS).

The purpose of the study was to evaluate the efficacy and safety of vitamin D3 at 4000 IU/day as a treatment option for aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) when compared with the usual care dose of 600 IU D3. We conducted a single site randomized, double-blind, phase 3 clinical trial in women with AIMSS comparing change in symptoms, reproductive hormones and AI pharmacokinetics. Postmenopausal women ≥18 years with stages I-IIIA breast cancer, taking AI and experiencing AIMSS [breast cancer prevention trial symptom scale-musculoskeletal (BCPT-MS) subscale ≥1.

Sex hormones, sex hormone binding globulin, and vertebral fractures in older men.

The association between sex hormones and sex hormone binding globin (SHBG) with vertebral fractures in men is not well studied. In these analyses, we determined whether sex hormones and SHBG were associated with greater likelihood of vertebral fractures in a prospective cohort study of community dwelling older men. We included data from participants in MrOS who had been randomly selected for hormone measurement (N=1463, including 1054 with follow-up data 4.

Findings From the National Machine Guarding Program: A Small Business Intervention: Lockout/Tagout.

Objective: Failure to implement lockout/tagout (LOTO) procedures adversely affects the rate of work-related fatalities and serious traumatic injury and is one of the most frequently cited Occupational Safety and Health Administration standards. This study assesses the impact of a nationwide intervention to improve LOTO in small metal fabrication businesses.

Methods: Insurance safety consultants conducted a standardized and validated evaluation of LOTO programs and procedures.

Serum Markers of Bone Turnover and Angiogenesis in Patients With Bisphosphonate-Related Osteonecrosis of the Jaw After Discontinuation of Long-Term Intravenous Bisphosphonate Therapy.

Purpose: To analyze serum markers of bone turnover, angiogenesis, endocrine function, and inflammation in patients with bisphosphonate-related osteonecrosis of the jaw (BRONJ) who discontinued long-term intravenous bisphosphonate (BP) therapy.

Patients And Methods: Serum samples were obtained from 25 BRONJ patients who had discontinued long-term intravenous BP therapy for an average of 11.4 ± 8.

Development and validation of the Screen for Early Eating Disorder Signs (SEEDS) in persons with type 1 diabetes.

This study's objective was to develop and validate an instrument to identify those at risk of developing an eating disorder (ED) in persons with type 1 diabetes. The Screen for Early Eating Disorder Signs (SEEDS) instrument was developed using a multi-phase process including focus groups, cognitive interviews, and mailed questionnaires. Factor analysis revealed 20 items across three factors (Body Image, Feelings, Quality of Life) demonstrating strong psychometric properties.

Clinical utility of routine laboratory testing to identify possible secondary causes in older men with osteoporosis: the Osteoporotic Fractures in Men (MrOS) Study.

Unlabelled: We investigated the value of routine laboratory testing for identifying underlying causes in older men diagnosed with osteoporosis. Most osteoporotic and nonosteoporotic men had ≥1 laboratory abnormality. Few individual laboratory abnormalities were more common in osteoporotic men.

Pain and falls and fractures in community-dwelling older men.

Background: Pain may reduce stability and increase falls and subsequent fractures in older men.

Objectives: To examine the association between joint pain and any pain with falls, hip and non-spine fractures in older community-dwelling men.

Design: A cohort study.

Prediction of Incident Major Osteoporotic and Hip Fractures by Trabecular Bone Score (TBS) and Prevalent Radiographic Vertebral Fracture in Older Men.

Trabecular bone score (TBS) has been shown to predict major osteoporotic (clinical vertebral, hip, humerus, and wrist) and hip fractures in postmenopausal women and older men, but the association of TBS with these incident fractures in men independent of prevalent radiographic vertebral fracture is unknown. TBS was estimated on anteroposterior (AP) spine dual-energy X-ray absorptiometry (DXA) scans obtained at the baseline visit for 5979 men aged ≥65 years enrolled in the Osteoporotic Fractures in Men (MrOS) Study and its association with incident major osteoporotic and hip fractures estimated with proportional hazards models. Model discrimination was tested with Harrell's C-statistic and with a categorical net reclassification improvement index, using 10-year risk cutpoints of 20% for major osteoporotic and 3% for hip fractures.

National Machine Guarding Program: Part 2. Safety management in small metal fabrication enterprises.

Background: Small manufacturing businesses often lack important safety programs. Many reasons have been set forth on why this has remained a persistent problem.

Methods: The National Machine Guarding Program (NMGP) was a nationwide intervention conducted in partnership with two workers' compensation insurers.

National Machine Guarding Program: Part 1. Machine safeguarding practices in small metal fabrication businesses.

Background: Metal fabrication workers experience high rates of traumatic occupational injuries. Machine operators in particular face high risks, often stemming from the absence or improper use of machine safeguarding or the failure to implement lockout procedures.

Methods: The National Machine Guarding Program (NMGP) was a translational research initiative implemented in conjunction with two workers' compensation insures.

Abdominal aortic calcification and risk of fracture among older women - The SOF study.

Data concerning the link between severity of abdominal aortic calcification (AAC) and fracture risk in postmenopausal women are discordant. This association may vary by skeletal site and duration of follow-up. Our aim was to assess the association between the AAC severity and fracture risk in older women over the short- and long term.