Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers.

Background: Families have faced unprecedented challenges during the COVID-19 pandemic, leading to increased maternal mental health problems and barriers to accessing care. Innovative programs are needed to support both maternal mental health and parenting, and to buffer the long-term impacts of stress on young children. Using a patient-oriented approach, our research team aimed to co-develop and pilot test an App-based psychoeducation and social-connection platform: Building Emotional Awareness and Mental Health (BEAM).

Factors Related to the Use of Topical vs. Oral NSAIDs for Sprains, Strains, and Contusions in a Senior Population: A Retrospective Analysis of Administrative Claims Data.

Background: Research to date on sprains, strains, and contusions has focused mainly on the analysis of sports-related injuries, occupational injuries, injuries resulting from automobile accidents, and severe injuries that result in inpatient hospital stays. Little is known about real-world acute sprains, strains, and contusions in an aging population. Patients may be treated with over-the-counter, oral, non-steroidal anti-inflammatory drugs (NSAIDs) for acute sprains, strains, and contusions or may require the use of prescription NSAIDs.

Hot flush frequency and severity at baseline as predictors of time to transient and stable treatment success: pooled analysis of two CE/BZA studies.

Objective: To evaluate the impact of baseline hot flush frequency and severity on time to symptom improvement during treatment with conjugated estrogens/bazedoxifene (CE/BZA).

Methods: Data were pooled through week 12 from two randomized placebo-controlled trials (SMART-1 and SMART-2) of nonhysterectomized postmenopausal women with hot flushes treated with CE 0.45 mg/BZA 20 mg or CE 0.

Time to first occurrence of breast pain and vaginal bleeding in phase 3 trials of CE/BZA.

Objective: In studies of the menopausal therapy, conjugated estrogens/bazedoxifene, breast pain and vaginal bleeding rates were comparable to placebo and lower than conjugated estrogens/medroxyprogesterone acetate (MPA). This post hoc analysis determined median time to occurrence of these events.

Methods: Participants in phase 3 conjugated estrogens/bazedoxifene trials recorded breast pain and vaginal bleeding in daily diaries.

Time to transient and stable reductions in hot flush frequency in postmenopausal women using conjugated estrogens/bazedoxifene.

Objective: This post hoc analysis estimates time to transient and stable reductions in hot flush frequency in postmenopausal women using conjugated estrogens/bazedoxifene.

Methods: In the 12-week Selective estrogens, Menopause, And Response to Therapy (SMART)-2 trial of conjugated estrogens/bazedoxifene 0.45 mg/20 mg and 0.

Informal Care Time and Cost in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Change Observed.

Introduction: We evaluate the association between caregiver (informal) time/cost and illness severity from two recently completed clinical trials of an investigational drug for Alzheimer's disease (AD).

Methods: Changes from baseline caregiver time were calculated and treatment effects analyzed using a restricted maximum likelihood-based mixed model for repeated measures. Four separate models were then estimated to examine the association between caregiver time costs and the clinical endpoints measured during the trials, including cognition (MMSE), function (DAD), behavior (NPI), global disability (CDR) and dependence (DS).

COPD exacerbations associated with the modified Medical Research Council scale and COPD assessment test among Humana Medicare members.

Background: The Global initiative for chronic Obstructive Lung Disease guidelines recommend assessment of COPD severity, which includes symptomatology using the modified Medical Research Council (mMRC) or COPD assessment test (CAT) score in addition to the degree of airflow obstruction and exacerbation history. While there is great interest in incorporating symptomatology, little is known about how patient reported symptoms are associated with future exacerbations and exacerbation-related costs.

Methods: The mMRC and CAT were mailed to a randomly selected sample of 4,000 Medicare members aged >40 years, diagnosed with COPD (≥2 encounters with International Classification of Dis eases-9th Edition Clinical Modification: 491.

Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Changes Observed.

Objective: To evaluate the performance (in terms of responsiveness to change, associations with other criterion standards, and indicators of Alzheimer's disease [AD] severity) of a quality-of-life measure (Quality of Life in Alzheimer's Disease [QOL-AD]) and a health utility measure (Health Utilities Index Mark 3 [HUI-3]) from two recently completed clinical trials of a new drug for AD.

Methods: Change from baseline scores was calculated, and treatment effects were analyzed using mixed models for repeated measures. Three separate models were then estimated to examine the association between the quality-of-life/utility end points and the clinical and other health outcome end points measured during the trials, including cognition, function, behavior, and dependence.

The Association Between Vulvovaginal Atrophy Symptoms and Quality of Life Among Postmenopausal Women in the United States and Western Europe.

Background: Vulvovaginal atrophy (VVA) is a condition associated with decreased estrogenization of the vaginal tissue, which can result in vaginal dryness, irritation, and dyspareunia. This study quantified the burden associated with VVA symptoms across the United States and Europe and compared this burden with other chronic conditions.

Methods: Data were analyzed from the International Women's Health Study, a cross-sectional Internet survey of women aged 40-75 years in the United States and Europe.

Longitudinal costs of caring for people with Alzheimer's disease.

Background: There has been an increasing interest in the relationship between severity of disease and costs in the care of people with dementia. Much of the current evidence is based on cross-sectional data, suggesting the need to examine trends over time for this important and growing cohort of the population.

Methods: This paper estimates resource use and costs of care based on longitudinal data for 72 people with dementia in Ireland.

Evaluating disease-modifying agents: a simulation framework for Alzheimer's disease.

Background: Considerable advances have been made in modeling Alzheimer's disease (AD), with a move towards individual-level rather than cohort models and simulations that consider multiple dimensions when evaluating disease severity. However, the possibility that disease-modifying agents (DMAs) may emerge requires an update of existing modeling frameworks.

Objectives: The aim of this study was to develop a simulation allowing for economic evaluation of DMAs in AD.

Household members of persons with Alzheimer's disease: health conditions, healthcare resource use, and healthcare costs.

Objectives: To compare medical condition burden, healthcare resource use, and healthcare costs of household members (HHMs) of individuals diagnosed with Alzheimer's disease (AD) with those of HHMs of matched individuals without AD.

Design: Retrospective cohort study based on administrative claims data collected between January 1, 2007, and December 31, 2011.

Setting: Medicare Advantage Prescription Drug (MAPD) plan.

Gender and patient complaints: are they related?

Background: Several studies suggest that the gender of patients and their healthcare providers affects overall patient satisfaction.

Aims: We sought to determine whether the gender of patients or providers was associated with the number of complaints filed by patients against providers.

Methods: In this case-controlled study, complaints from a health maintenance organisation were analysed for gender disparity during a 12-month period.

Effects of bazedoxifene/conjugated estrogens on quality of life in postmenopausal women with symptoms of vulvar/vaginal atrophy.

Objective: To evaluate the effects of the tissue selective estrogen complex (TSEC) pairing bazedoxifene (BZA) with conjugated estrogens (CE) on sexual function and quality of life in postmenopausal women.

Methods: In this 12-week, double-blind, placebo-controlled study, postmenopausal, non-hysterectomized women (n = 652) with symptoms of moderate to severe vulvar/vaginal atrophy were randomized to once-daily treatment with BZA 20 mg/CE 0.45 or 0.

Bazedoxifene/conjugated estrogens and quality of life in postmenopausal women.

Objective: To assess the effects of bazedoxifene/conjugated estrogens (BZA/CE) on sleep parameters and health-related quality of life (HR-QOL).

Methods: This was a 12-week, multicenter, double-blind, placebo-controlled phase 3 study. Postmenopausal women with an intact uterus and experiencing >or=7 moderate-to-severe hot flushes daily were randomized to BZA 20 mg/CE 0.

Working conditions in primary care: physician reactions and care quality.

Background: Adverse primary care work conditions could lead to a reduction in the primary care workforce and lower-quality patient care.

Objective: To assess the relationship among adverse primary care work conditions, adverse physician reactions (stress, burnout, and intent to leave), and patient care.

Design: Cross-sectional analysis.

Cross-geographic region differences in quality of life in women with and without vertebral fracture.

Summary: Not much is known about cross-geographic region differences in quality of life (QoL) in women with and without prevalent vertebral fractures (VFX). QoL differed between continents, countries, and ethnicities. The observed differences in QoL mostly appeared larger than the difference in QoL between women with or without mild to moderate VFX.

Separate and unequal: clinics where minority and nonminority patients receive primary care.

Background: Few studies have examined the influence of physician workplace conditions on health care disparities. We compared 96 primary care clinics in New York, New York, and in the upper Midwest serving various proportions of minority patients to determine differences in workplace organizational characteristics.

Methods: Cross-sectional data are from surveys of 96 clinic managers, 388 primary care physicians, and 1701 of their adult patients with hypertension, diabetes mellitus, or congestive heart failure participating in the Minimizing Error, Maximizing Outcome (MEMO) study.

Identifying meaningful differences in vasomotor symptoms among menopausal women.

Objective: First, to identify treatment satisfaction thresholds for interpreting treatment-related changes in vasomotor symptoms, and, second, to determine the doses of desvenlafaxine (DVS) (administered as desvenlafaxine succinate) that effectively provide relief of vasomotor symptoms considered important by menopausal women.

Design: Efficacy and treatment satisfaction were assessed in 620 postmenopausal women with moderate to severe vasomotor symptoms participating in a double-blind, placebo-controlled trial and randomly assigned to placebo or 50, 100, 150, or 200 mg DVS. Number and severity of hot flushes and number of nighttime awakenings were recorded in daily diaries for 12 weeks of treatment.

Part-time physicians...prevalent, connected, and satisfied.

Objective: The health care workforce is evolving and part-time practice is increasing. The objective of this work is to determine the relationship between part-time status, workplace conditions, and physician outcomes.

Design: Minimizing error, maximizing outcome (MEMO) study surveyed generalist physicians and their patients in the upper Midwest and New York City.

Rationale and methods for a trial assessing placebo, echinacea, and doctor-patient interaction in the common cold.

Background: Clinical medicine and healthcare policy are increasingly guided by randomized controlled trials, which in turn are dependent on the validity of placebo control. It is important to understand the effects of placebo control on outcome measurement, especially for assessment of symptoms and functional impairments where subjectivity, expectancy, and motivation may significantly impact outcome evaluation. This paper describes the rationale and methodology of a trial designed to evaluate placebo effects related to taking pills and to compare these with effects attributable to standard or enhanced (patient-oriented) doctor-patient interaction.

Randomized-controlled trial of a telephone and mail intervention for alcohol use disorders: three-month drinking outcomes.

Background: Alcohol screening, brief intervention, and referral to specialized treatment (ASBIR) reduce drinking and related harms. Unanswered questions are how to manage nondependent patients with poor response to brief interventions, how to manage dependent patients who do not obtain treatment, and how to ensure population-wide delivery of ASBIR. Telephone-administered counseling may provide answers.

Pharmacoepidemiology of potential alcohol-prescription drug interactions among primary care patients with alcohol-use disorders.

Objective: To report on the proportion of individuals with alcohol-use disorders who take prescription medications that could interact with alcohol and on the proportion who recall advice to avoid alcohol with their medications.

Design: Secondary analysis of a randomized controlled trial of telephone counseling.

Setting: 18 primary care practices in south-central and southeastern Wisconsin.

Development and preliminary validation of the Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ).

Objective: The Menopause Symptoms Treatment Satisfaction Questionnaire, an eight-item questionnaire with a 4-week recall period, was developed to assess women's satisfaction with treatment for symptoms associated with menopause. We describe the development and initial testing of the scale.

Design: Following standard instrument-development procedures, focus groups were conducted with menopausal women experiencing hot flushes to generate potential constructs.

DARPP-32 involvement in the photic pathway of the circadian system.

The multifunctional regulator of protein kinases and phosphatases dopamine- and cAMP-regulated phosphoprotein of 32 kDa (DARPP-32) is an important molecular target of the dopamine signaling pathway. In the present study, we investigated the possible involvement of DARPP-32 regulation in the circadian system using DARPP-32 knock-out (KO) mice. These mice showed normal entrainment to a 12 h light/dark cycle and free run in constant darkness with a period similar to that of wild-type controls.