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A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS): Rationale, design, and uptake of online study intervention material

Wed, 05/10/2017 - 9:24am

OBJECTIVE: To develop an innovative and effective educational intervention to inform patients about the need for osteoporosis treatment and to determine factors associated with its online uptake.

METHODS: Postmenopausal women with a prior fracture and not currently using osteoporosis therapy were eligible to be included in the Activating Patients at Risk for OsteoPOroSis (APROPOS). Four nominal groups with a total of 18 racially/ethnically diverse women identified osteoporosis treatment barriers. We used the Information, Motivation, Behavior Skills conceptual model to develop a direct-to-patient intervention to mitigate potentially modifiable barriers to osteoporosis therapy. The intervention included videos tailored by participants' race/ethnicity and their survey responses: ranked barriers to osteoporosis treatment, deduced barriers to treatment, readiness to behavior change, and osteoporosis treatment history. Videos consisted of "storytelling" narratives, based on osteoporosis patient experiences and portrayed by actresses of patient-identified race/ethnicity. We also delivered personalized brief phone calls followed by an interactive voice-response phone messages aimed to promote uptake of the videos.

RESULTS: To address the factors associated with online intervention uptake, we focused on participants assigned to the intervention arm (n = 1342). These participants were 92.9% Caucasian, with a mean (SD) age 74.9 (8.0) years and the majority (77.7%) had some college education. Preference for natural treatments was the barrier ranked #1 by most (n = 130; 27%), while concern about osteonecrosis of the jaw was the most frequently reported barrier (at any level; n = 322; 67%). Overall, 28.1% (n = 377) of participants in the intervention group accessed the videos online. After adjusting for relevant covariates, the participants who provided an email address had 6.07 (95% CI 4.53-8.14) higher adjusted odds of accessing their online videos compared to those who did not.

CONCLUSION: We developed and implemented a novel tailored multi-modal intervention to improve initiation of osteoporosis therapy. An email address provided on the survey was the most important factor independently associated with accessing the intervention online. The design and uptake of this intervention may have implications for future studies in osteoporosis or other chronic diseases.

Decade-Long Trends (2001 to 2011) in the Use of Evidence-Based Medical Therapies at the Time of Hospital Discharge for Patients Surviving Acute Myocardial Infarction

Wed, 05/10/2017 - 9:23am

Optimization of medical therapy during discharge planning is vital for improving patient outcomes after hospitalization for acute myocardial infarction (AMI). However, limited information is available about recent trends in the prescribing of evidence-based medical therapies in these patients, especially from a population-based perspective. We describe decade-long trends in the discharge prescribing of aspirin, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, beta blockers, and statins in hospital survivors of AMI. The study population consisted of 5,253 patients who were discharged from all 11 hospitals in central Massachusetts after AMI in 6 biennial periods from 2001 to 2011. Combination medical therapy (CMT) was defined as the prescription of all 4 cardiac medications at hospital discharge. The average age of this patient population was 69.2 years and 57.7% were men. Significant increases were observed in the use of CMT, from 25.6% in 2001 to 48.7% in 2011, with increases noted for each of the individual cardiac medications examined. Subgroup analysis also showed improvement in discharge prescriptions for P2Y12 inhibitors in patients who underwent a percutaneous coronary intervention. Presence of a do-not-resuscitate order, before co-morbidities, hospitalization for non-ST-segment elevation myocardial infarction, admission to a nonteaching hospital, and failure to undergo cardiac catheterization or a percutaneous coronary intervention were associated with underuse of CMT. In conclusion, our study demonstrates encouraging trends in the prescribing of evidence-based medications at hospital discharge for AMI. However, certain patient subgroups continue to be at risk for underuse of CMT, suggesting the need for strategies to enhance compliance with current practice guidelines.

Rheumatoid arthritis triple therapy compared with etanercept: difference in infectious and gastrointestinal adverse events

Wed, 05/10/2017 - 9:23am

Objective.: The main aim of this study was to examine the differences between triple therapy (T: SSZ and HCQ added to MTX) and etanercept (E) added to MTX with regard to the infectious and gastrointestinal (GI) adverse events (AEs) reported in The Rheumatoid Arthritis Comparison of Active Therapies Trial.

Methods.: The patients were 353 RA MTX incomplete responders who were randomized to T (n = 178) or E (n = 175). Of these, 88 patients were switched to the alternative treatment from the initial treatment (E or T) at 24 weeks per protocol. Infectious and GI serious AEs (SAEs) and non-serious AEs (NAEs) were reported during 48 and 4 weeks after the intervention period. Generalized linear models were used to estimate the incidence rate ratios (IRRs) of AEs between the two therapies.

Results.: Patients on E therapy were more likely to have infectious NAEs (IRR = 1.56, 95% CI: 1.11, 2.19). There was a greater number of infectious SAEs that occurred when patients received E than T therapy [12 E (6.9%) vs 4 T (2.2%), P = 0.19]. Pneumonia was the most common infectious SAE for both treatments [6 E (3.4%) and 2 T (1.1%)]. Conversely, patients who were on E were less likely to have GI NAEs than those on T therapy (IRR = 0.62, 95% CI: 0.40, 0.94). The most common GI SAE reported was GI haemorrhage, which occurred among three patients on E (1.7%).

Conclusion.: This study provides evidence of different likelihoods of infectious and GI AEs associated with two common, equally effective treatments for RA patients who have had incomplete responses to MTX.

Use of Risk Models to Predict Death in the Next Year Among Individual Ambulatory Patients With Heart Failure

Wed, 05/10/2017 - 9:23am

Importance: The clinical practice guidelines for heart failure recommend the use of validated risk models to estimate prognosis. Understanding how well models identify individuals who will die in the next year informs decision making for advanced treatments and hospice.

Objective: To quantify how risk models calculated in routine practice estimate more than 50% 1-year mortality among ambulatory patients with heart failure who die in the subsequent year.

Design, Setting, and Participants: Ambulatory adults with heart failure from 3 integrated health systems were enrolled between 2005 and 2008. The probability of death was estimated using the Seattle Heart Failure Model (SHFM) and the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) risk calculator. Baseline covariates were collected from electronic health records. Missing covariates were imputed. Estimated mortality was compared with actual mortality at both population and individual levels.

Main Outcomes and Measures: One-year mortality.

Results: Among 10930 patients with heart failure, the median age was 77 years, and 48.0% of these patients were female. In the year after study enrollment, 1661 patients died (15.9% by life-table analysis). At the population level, 1-year predicted mortality among the cohort was 9.7% for the SHFM (C statistic of 0.66) and 17.5% for the MAGGIC risk calculator (C statistic of 0.69). At the individual level, the SHFM predicted a more than 50% probability of dying in the next year for 8 of the 1661 patients who died (sensitivity for 1-year death was 0.5%) and for 5 patients who lived at least a year (positive predictive value, 61.5%). The MAGGIC risk calculator predicted a more than 50% probability of dying in the next year for 52 of the 1661 patients who died (sensitivity, 3.1%) and for 63 patients who lived at least a year (positive predictive value, 45.2%). Conversely, the SHFM estimated that 8496 patients (77.8%) had a less than 15% probability of dying at 1 year, yet this lower-risk end of the score range captured nearly two-thirds of deaths (n = 997); similarly, the MAGGIC risk calculator estimated a probability of dying of less than 25% for the majority of patients who died at 1 year (n = 914).

Conclusions and Relevance: Although heart failure risk models perform reasonably well at the population level, they do not reliably predict which individual patients will die in the next year.

Einstein, measurement, and prediction

Wed, 05/10/2017 - 9:23am

Delgado-Gomez et al. (2016) have provided an interesting example of the comparison of computerized adaptive testing (CAT) based on unidimensional item response theory (IRT) and a machine learning approach based on decision trees (DT) in the prediction of people who have a history of suicide attempts. ... In the following we attempt to better articulate the differences between the two statistical approaches so that practitioners and consumers of these methods will have a better understanding of their utilities.

Longitudinal analysis of changes in weight and waist circumference in relation to incident vasomotor symptoms: the Study of Women's Health Across the Nation (SWAN)

Wed, 05/10/2017 - 9:23am

OBJECTIVE: Greater body mass index (BMI) and body fat are associated with vasomotor symptoms (VMS). Thus, weight loss may prevent VMS. We analyzed whether concurrent BMI or waist circumference and/or changes in weight or waist circumference predicted incident VMS and whether these relations differed by menopause stage or race/ethnicity.

METHODS: Data from 10 follow-up visits for 1,546 participants in the Study of Women's Health Across the Nation who reported no VMS at baseline were modeled for time to first symptomatic visit in relation to concurrent BMI and waist circumference and change in weight and waist circumference during early and late menopause using discrete survival analyses, adjusting for covariates.

RESULTS: Greater concurrent BMI and waist circumference were significantly related to greater any and frequent (>/=6 d in the last 2 wk) incident VMS in early menopause and lower VMS risk in late menopause. Percentage weight change since baseline and since the prior visit was unrelated to incident any VMS in either menopause stage. Percentage weight change since baseline had a significant shallow U-shaped association with incident frequent VMS in early menopause (P = 0.02), a shallow inverse U-shape in late menopause (P = 0.02), and a significant interaction with menopause stage (P = 0.004) but not with race/ethnicity. Recent weight change was unassociated with incident VMS in either menopause stage. Results were similar for waist change.

CONCLUSIONS: Concurrent BMI and waist circumference were positively related to incident VMS in early menopause and negatively related in late menopause. Maintaining healthy weight in early menopause may help prevent VMS.

Links between reproductive factors and general health

Wed, 05/10/2017 - 9:23am

In this issue of Menopause, the current study of the Women’s Health Initiative participants by Shadyab et al. adds a novel focus on extreme longevity, finding that survival to 90+ years was associated with later age at menarche, later age at natural or surgical menopause, and longer reproductive lifespan, with the last factor reflecting primarily age at menopause. Based on the multitude of studies, it is clear that reproductive factors are tied to more general measures of health.

Taking the STING out of TLR-driven autoimmune diseases: good, bad, or indifferent

Wed, 05/10/2017 - 9:23am

Both endosomal and cytosolic-nucleic acid-sensing receptors can detect endogenous ligands and promote autoimmunity and autoinflammation. These responses involve a complex interplay among and between the cytosolic and endosomal sensors involving both hematopoietic and radioresistant cells. Cytosolic sensors directly promote inflammatory responses through the production of type I IFNs and proinflammatory cytokines. Inflammation-associated tissue damage can further promote autoimmune responses indirectly, as receptor-mediated internalization of the resulting cell debris can activate endosomal Toll-like receptors (TLR). Both endosomal and cytosolic receptors can also negatively regulate inflammatory responses. A better understanding of the factors and pathways that promote and constrain autoimmune diseases will have important implications for the development of agonists and antagonists that modulate these pathways.

Barriers and Facilitators to Deaf Trauma Survivors' Help-Seeking Behavior: Lessons for Behavioral Clinical Trials Research

Wed, 05/10/2017 - 9:23am

Deaf individuals experience significant obstacles to participating in behavioral health research when careful consideration is not given to accessibility during the design of study methodology. To inform such considerations, we conducted an exploratory secondary analysis of a mixed-methods study that originally explored 16 Deaf trauma survivors' help-seeking experiences. Our objective was to identify key findings and qualitative themes from consumers' own words that could be applied to the design of behavioral clinical trials methodology. In many ways, the themes that emerged were not wholly dissimilar from the general preferences of members of other sociolinguistic minority groups-a need for communication access, empathy, respect, strict confidentiality procedures, trust, and transparency of the research process. Yet, how these themes are applied to the inclusion of Deaf research participants is distinct from any other sociolinguistic minority population, given Deaf people's unique sensory and linguistic characteristics. We summarize our findings in a preliminary "Checklist for Designing Deaf Behavioral Clinical Trials" to operationalize the steps researchers can take to apply Deaf-friendly approaches in their empirical work.

Informed Family Member Involvement to Improve the Quality of Dementia Care in Nursing Homes

Wed, 05/10/2017 - 9:23am

OBJECTIVES: To describe the extent to which nursing homes engaged families in antipsychotic initiation decisions in the year before surveyor guidance revisions were implemented.

DESIGN: Mixed-methods study based on semistructured interviews.

SETTING: U.S. nursing homes (N = 20) from five CMS regions (III, IV, VI, VIII, IX).

PARTICIPANTS: Family members of nursing home residents (N = 41).

MEASUREMENTS: Family member responses to closed- and open-ended questions regarding involvement in resident care and antipsychotic initiation. Two researchers used a content analytical approach to code open responses to themes of family involvement in behavior management, decision-making, knowledge of risks and benefits, and informed consent.

RESULTS: Fifty-four percent of family members felt highly involved in decisions about behavior management. Forty-two percent recalled being asked how to manage resident behavior without medication, and 17% recalled receipt of information about antipsychotic risks and benefits. Sixty-six percent felt highly involved in the process of initiating antipsychotic medication; 24% reported being asked for input into the antipsychotic initiation decision and knowing before the antipsychotic was started.

CONCLUSION: Under existing federal regulations but before guidance revisions were implemented in 2013, more than 40% of families reported being involved in nonpharmacological behavior management of family members, but fewer than one in four reported being involved throughout the entire antipsychotic prescribing process. Interventions that standardize family engagement and promote adherence to existing federal regulations are needed. This discussion builds on these findings to weigh the policy options of greater enforcement of existing regulations versus enactment of new legislation to address this challenging issue.

Clinical trials of biosimilars should become more similar

Wed, 05/10/2017 - 9:23am

As many more biosimilars are in development, we recommend that clinical trial design be standardised. This standardisation could be agreed upon and overseen by regulatory agencies around the world. The introduction of consistency across clinical trials should increase confidence in these more affordable biopharmaceuticals, both within the healthcare community and among patients.

The Patient Safety Screener: Validation of a Brief Suicide Risk Screener for Emergency Department Settings

Wed, 05/10/2017 - 9:22am

This study evaluated the concurrent validity of a brief suicide risk screener for adults in the emergency department (ED). Two versions of the verbally administered Patient Safety Screener (2-item, 3-item) were compared to a reference standard, the Beck Scale for Suicide Ideation (BSSI). Analyses included measures of agreement (Kappa). Agreement between the Patient Safety Screener-2 and -3 and the BSSI (n = 951) was almost perfect for overall positive screening (K = 0.94-0.95) and past suicide attempts (K = 0.97-0.98). Agreement on ideation ranged from fair (K = 0.34) for the 2 item version to good (K = 0.61) for the 3 item version. The Patient Safety Screener's concurrent validity with the BSSI ranged from fair to almost perfect and warrants additional study.

Richard Aghababian Papers: A Finding Aid

Tue, 05/09/2017 - 3:39pm

The Richard Aghababian Papers chronicle Aghababian’s time as a student, professor, and department head at University of Massachusetts Medical School.

Robin I. Davidson Papers: A Finding Aid

Tue, 05/09/2017 - 3:39pm

The Robin I. Davidson Papers chronicle the career of Dr. Davidson as a neurosurgeon, an educator, and an administrator.

Department of Microbiology and Physiological Systems (MaPS) Papers, 2010 - present (formerly Department of Physiology, 1968 – 2009): A Finding Aid

Tue, 05/09/2017 - 3:39pm

The Department of Microbiology and Physiological Systems (MaPS) Papers document the establishment of the Department of Physiology and chronicle its early history, development, and merger with the Department of Microbiology to form the Department of Microbiology and Physiological Systems (MaPS).

A. Robert Schell Papers: A Finding Aid

Tue, 05/09/2017 - 3:39pm

The A. Robert Schell Papers chronicle A. Robert Schell’s time as a student in the first class of the University of Massachusetts Medical School.

Union Medical Association Papers (1758 – 1858): A Finding Aid

Tue, 05/09/2017 - 3:39pm

The Union Medical Association was officially established at Blackstone Village, Mendon, Massachusetts, on May 12, 1834 by local doctors Hiram Allen, Abel Wilder, Metcalf Marsh, Ariel Ballou and Moses D. Southwick. The goal of the Union Medical Association was to maintain and advance the medical knowledge of its members. This collection includes reports and transcripts of lectures on interesting medical cases, new remedies, medical ethics, and statistics created from 1834 to 1858 by the Association’s members. Also included in this collection are autograph letters of different French, English, and American physicians dated 1758 - 1836. Currently, the papers of the Union Medical Association are the part of the Worcester District Medical Society collection housed at the Worcester Historical Museum.

Samuel B. Woodward Papers (1806 – 1848): A Finding Aid

Tue, 05/09/2017 - 3:39pm

Samuel Bayard Woodward, M.D., (1787-1850), physician, educator, and publicist, was the first superintendent (1832-1846) of the State Lunatic Hospital (later the Worcester Recovery Center and Hospital) and the co-founder and first president (1844-1848) of the Association of Medical Superintendents of American Institutions for the Insane (later the American Psychiatric Association). This collection contains digitized versions of essays, addresses, obituaries, letters, and verses created by Woodward from 1806 to 1848 and cover various medical, social, financial, educational, and personal topics.

Worcester Foundation for Biomedical Research (WFBR) Papers, 1944 – 1997 [formerly Worcester Foundation for Experimental Biology (WFEB)]: A Finding Aid

Tue, 05/09/2017 - 3:39pm

The Worcester Foundation for Biomedical Research (formerly Worcester Foundation for Experimental Biology) was established in 1944 in Shrewsbury, Massachusetts by Dr. Gregory Pincus and Dr. Hudson Hoagland. This collection documents the Worcester Foundation history and development until its 1997 merger with the University of Massachusetts Medical School in Worcester, Massachusetts. Also included in this collection are materials related to the Worcester Foundation for Biomedical Research faculty members.

High-Throughput Screening of Tyrosine Kinase Inhibitor Resistant Genes in CML

Tue, 05/09/2017 - 11:27am

Genome-wide RNA interference (RNAi) screening in mammalian cells has proven to be a powerful tool for identifying new genes and molecular pathways relevant to many cellular processes and diseases. For example, screening for genes that, when inactivated, lead to resistance to cancer therapeutic drugs can reveal new mechanisms for how resistance develops and identify potential targetable strategies to overcome drug resistance. Here, we describe a detailed procedure for performing a high-throughput RNAi screen using a genome-wide human short hairpin RNA (shRNA) library for identifying tyrosine kinase inhibitor (TKI)-resistance genes in a human CML cell line model.