Samuel Merritt University

This article tells how a hospital nursing director sought out and effectively used an educational nurse consultant to help establish a more unified, progressive working group in a health institution, including a three-year school for nurses, as well as the department of nursing.

In 2015, approximately 244 million people were transnational migrants, approximately half of whom were workers, often engaged in jobs that are hazardous to their health. They work for less pay, for longer hours, and in worse conditions than do nonmigrants and are often subject to human rights violations, abuse, human trafficking, and violence. Worldwide, immigrant workers have higher rates of adverse occupational exposures and working conditions, which lead to poor health outcomes, workplace injuries, and occupational fatalities. Health disparities of immigrant workers are related to environmental and occupational exposures and are a result of language/cultural barriers, access to health care, documentation status, and the political climate of the host country. Recommendations on global and local scales are offered as potential solutions to improving the health of immigrant workers.

Hyperkinetic movements are unwanted or excess movements that are frequently seen in children with neurologic disorders. They are an important clinical finding with significant implications for diagnosis and treatment. However, the lack of agreement on standard terminology and definitions interferes with clinical treatment and research. We describe definitions of dystonia, chorea, athetosis, myoclonus, tremor, tics, and stereotypies that arose from a consensus meeting in June 2008 of specialists from different clinical and basic science fields. Dystonia is a movement disorder in which involuntary sustained or intermittent muscle contractions cause twisting and repetitive movements, abnormal postures, or both. Chorea is an ongoing random-appearing sequence of one or more discrete involuntary movements or movement fragments. Athetosis is a slow, continuous, involuntary writhing movement that prevents maintenance of a stable posture. Myoclonus is a sequence of repeated, often nonrhythmic, brief shock-like jerks due to sudden involuntary contraction or relaxation of one or more muscles. Tremor is a rhythmic back-and-forth or oscillating involuntary movement about a joint axis. Tics are repeated, individually recognizable, intermittent movements or movement fragments that are almost always briefly suppressible and are usually associated with awareness of an urge to perform the movement. Stereotypies are repetitive, simple movements that can be voluntarily suppressed. We provide recommended techniques for clinical examination and suggestions for differentiating between the different types of hyperkinetic movements, noting that there may be overlap between conditions. These definitions and the diagnostic recommendations are intended to be reliable and useful for clinical practice, communication between clinicians and researchers, and for the design of quantitative tests that will guide and assess the outcome of future clinical trials.

Background: Previous studies have shown that virtual reality (VR) is effective in reducing acute and chronic pain both in adults and in children. Given the emergence of new VR technology, and the growing body of research surrounding VR and pain management, an updated systematic review is warranted. Purpose: The purpose of this systematic review is to compare the effectiveness of VR in reducing acute and chronic pain in adults. Data Sources: A search was conducted in three databases (PubMed, CINAHL, Trip) using standardized search terms. Study Selection: Twenty experimental and quasi-experimental trials published between January 2007 and December 2018 were included based on prespecified inclusion and exclusion criteria. Pain intensity was the primary outcome. Data Extraction: We extracted data and appraised the quality of articles using either the PEDro or Modified Downs and Black risk of bias tools. Data Synthesis: The majority of studies supported the use of VR to reduce acute pain both during the procedure and immediately after. Numerous studies found VR reduced chronic pain during VR exposure but there is insufficient evidence to support lasting analgesia. There was considerable variability in patient population, pain condition and dosage of VR exposure. Limitations: Due to heterogeneity, we were unable to perform meta-analyses for all study populations and pain conditions. Conclusions: VR is an effective treatment for reducing acute pain. There is some research that suggests VR can reduce chronic pain during the intervention; however, more evidence is needed to conclude that VR is effective for lasting reductions in chronic pain. Keywords: virtual reality, analgesia, acute, chronic, pain management, adult

OBJECTIVES: Most studies of carpal tunnel syndrome (CTS) incidence and prevalence among workers have been limited by small sample sizes or restricted to a small subset of jobs. We established a common CTS case definition and then pooled CTS prevalence and incidence data across six prospective studies of musculoskeletal outcomes to measure CTS frequency and allow better studies of etiology. METHODS: Six research groups collected prospective data at > 50 workplaces including symptoms characteristic of CTS and electrodiagnostic studies (EDS) of the median and ulnar nerves across the dominant wrist. While study designs and the timing of data collection varied across groups, we were able to create a common CTS case definition incorporating both symptoms and EDS results from data that were collected in all studies. RESULTS: At the time of enrollment, 7.8% of 4321 subjects met our case definition and were considered prevalent cases of CTS. During 8833 person-years of follow-up, an additional 204 subjects met the CTS case definition for an overall incidence rate of 2.3 CTS cases per 100 person-years. CONCLUSIONS: Both prevalent and incident CTS were common in data pooled across multiple studies and sites. The large number of incident cases in this prospective study provides adequate power for future exposure-response analyses to identify work- and non-work-related risk factors for CTS. The prospective nature allows determination of the temporal relations necessary for causal inference.

Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption. Thirty-two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14-day run-in phase where they were treated with the standard of care (0.9% sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30% reepithelialization of the study ulcer after the run-in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% reepithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p = 0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects (p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment. IDRT could greatly enhance the treatment of nonhealing DFUs.

Dimensional analysis has been proposed by Schatzman as an alternate method for the generation of grounded theory. The intent of this article is to trace the evolution of dimensional analysis and describe it in relation to traditional grounded theory method. Analytic processes that characterize dimensional analysis will be reviewed, and a research exemplar is presented to illustrate the application of the dimensional analysis method.

OBJECTIVE: To present recommendations for athletic trainers and other allied health care professionals in the conservative management and prevention of ankle sprains in athletes. BACKGROUND: Because ankle sprains are a common and often disabling injury in athletes, athletic trainers and other sports health care professionals must be able to implement the most current and evidence-supported treatment strategies to ensure safe and rapid return to play. Equally important is initiating preventive measures to mitigate both first-time sprains and the chance of reinjury. Therefore, considerations for appropriate preventive measures (including taping and bracing), initial assessment, both short- and long-term management strategies, return-to-play guidelines, and recommendations for syndesmotic ankle sprains and chronic ankle instability are presented. RECOMMENDATIONS: The recommendations included in this position statement are intended to provide athletic trainers and other sports health care professionals with guidelines and criteria to deliver the best health care possible for the prevention and management of ankle sprains. An endorsement as to best practice is made whenever evidence supporting the recommendation is available.

1. Lesions of the biceps tendon may be a cause of painful shoulder. 2. The normal anatomical mechanics of the biceps tendon are faulty. A supratubercular ridge or flat bicipital groove increases the mechanical difficulties. 3. An operation to fix the tendon in the bicipital groove and to remove that portion of the tendon above the groove relieves the symptoms caused by it and does not materially weaken the shoulder.

Introduction: Research on disparities in health and health care has demonstrated that social, economic, and political factors are key drivers of poor health outcomes. Yet the role of such structural forces on health and health care has been incorporated unevenly into medical training. The framework of structural competency offers a paradigm for training health professionals to recognize and respond to the impact of upstream, structural factors on patient health and health care. Methods: We report on a brief, interprofessional structural competency curriculum implemented in 32 distinct instances between 2015 and 2017 throughout the San Francisco Bay Area. In consultation with medical and interprofessional education experts, we developed open-ended, written-response surveys to qualitatively evaluate this curriculum's impact on participants. Qualitative data from 15 iterations were analyzed via directed thematic analysis, coding language, and concepts to identify key themes. Results: Three core themes emerged from analysis of participants' comments. First, participants valued the curriculum's focus on the application of the structural competency framework in real-world clinical, community, and policy contexts. Second, participants with clinical experience (residents, fellows, and faculty) reported that the curriculum helped them reframe how they thought about patients. Third, participants reported feeling reconnected to their original motivations for entering the health professions. Discussion: This structural competency curriculum fills a gap in health professional education by equipping learners to understand and respond to the role that social, economic, and political structural factors play in patient and community health.

The psychological revolution that follows the onset of independent locomotion in the latter half of the infant's first year provides one of the best illustrations of the intimate connection between action and psychological processes. In this paper, we document some of the dramatic changes in perception-action coupling, spatial cognition, memory, and social and emotional development that follow the acquisition of independent locomotion. We highlight the range of converging research operations that have been used to examine the relation between locomotor experience and psychological development, and we describe recent attempts to uncover the processes that underlie this relation. Finally, we address three important questions about the relation that have received scant attention in the research literature. These questions include: (1) What changes in the brain occur when infants acquire experience with locomotion? (2) What role does locomotion play in the maintenance of psychological function? (3) What implications do motor disabilities have for psychological development? Seeking the answers to these questions can provide rich insights into the relation between action and psychological processes and the general processes that underlie human development.

The purpose of this study was to evaluate the effects of an 8-week program of hippotherapy on energy expenditure during walking; on the gait dimensions of stride length, velocity, and cadence; and on performance on the Gross Motor Function Measure (GMFM) in five children with spastic cerebral palsy (CP). A repeated-measures within-subjects design was used consisting of two baseline measurements taken 8 weeks apart, followed by an 8-week intervention period, then a posttest. After hippotherapy, all five children showed a significant decrease (X2(r)=7.6, P<0.05) in energy expenditure during walking and a significant increase (X2(r)=7.6, P<0.05) in scores on Dimension E (Walking, Running, and Jumping) of the GMFM. A trend toward increased stride length and decreased cadence was observed. This study suggests that hippotherapy may improve energy expenditure during walking and gross motor function in children with CP.

BACKGROUND: Between 2001 and 2010, five research groups conducted coordinated prospective studies of carpal tunnel syndrome (CTS) incidence among US workers from various industries and collected detailed subject-level exposure information with follow-up of symptoms, electrophysiological measures and job changes. OBJECTIVE: This analysis examined the associations between workplace biomechanical factors and incidence of dominant-hand CTS, adjusting for personal risk factors. METHODS: 2474 participants, without CTS or possible polyneuropathy at enrolment, were followed up to 6.5 years (5102 person-years). Individual workplace exposure measures of the dominant hand were collected for each task and included force, repetition, duty cycle and posture. Task exposures were combined across the workweek using time-weighted averaging to estimate job-level exposures. CTS case-criteria were based on symptoms and results of electrophysiological testing. HRs were estimated using Cox proportional hazard models. RESULTS: After adjustment for covariates, analyst (HR=2.17; 95% CI 1.38 to 3.43) and worker (HR=2.08; 95% CI 1.31 to 3.39) estimated peak hand force, forceful repetition rate (HR=1.84; 95% CI 1.19 to 2.86) and per cent time spent (eg, duty cycle) in forceful hand exertions (HR=2.05; 95% CI 1.34 to 3.15) were associated with increased risk of incident CTS. Associations were not observed between total hand repetition rate, per cent duration of all hand exertions, or wrist posture and incident CTS. CONCLUSIONS: In this prospective multicentre study of production and service workers, measures of exposure to forceful hand exertion were associated with incident CTS after controlling for important covariates. These findings may influence the design of workplace safety programmes for preventing work-related CTS.

REVIEW QUESTION/OBJECTIVE: The objective of this review is to identify the effectiveness of mindfulness based programs in reducing stress experienced by nurses in adult hospitalized patient care settings. BACKGROUND: Nursing professionals face extraordinary stressors in the medical environment. Many of these stressors have always been inherent to the profession: long work hours, dealing with pain, loss and emotional suffering, caring for dying patients and providing support to families. Recently nurses have been experiencing increased stress related to other factors such as staffing shortages, increasingly complex patients, corporate financial constraints and the increased need for knowledge of ever-changing technology. Stress affects high-level cognitive functions, specifically attention and memory, and this increases the already high stakes for nurses. Nurses are required to cope with very difficult situations that require accurate, timely decisions that affect human lives on a daily basis.Lapses in attention increase the risk of serious consequences such as medication errors, failure to recognize life-threatening signs and symptoms, and other essential patient safety issues. Research has also shown that the stress inherent to health care occupations can lead to depression, reduced job satisfaction, psychological distress and disruptions to personal relationships. These outcomes of stress are factors that create scenarios for risk of patient harm.There are three main effects of stress on nurses: burnout, depression and lateral violence. Burnout has been defined as a syndrome of depersonalization, emotional exhaustion, and a sense of low personal accomplishment, and the occurrence of burnout has been closely linked to perceived stress. Shimizu, Mizoue, Mishima and Nagata state that nurses experience considerable job stress which has been a major factor in the high rates of burnout that has been recorded among nurses. Zangaro and Soeken share this opinion and state that work related stress is largely contributing to the current nursing shortage. They report that work stress leads to a much higher turnover, especially during the first year after graduation, lowering retention rates in general.In a study conducted in Pennsylvania, researchers found that while 43% of the nurses who reported high levels of burnout indicated their intent to leave their current position, only 11% of nurses who were not burned out intended to leave in the following 12 months. In the same study patient-to-nurse ratios were significantly associated with emotional exhaustion and burnout. An increase of one patient per nurse assignment to a hospital's staffing level increased burnout by 23%.Depression can be defined as a mood disorder that causes a persistent feeling of sadness and loss of interest. Wang found that high levels of work stress were associated with higher risk of mood and anxiety disorders. In Canada one out of every 10 nurses have shown depressive symptoms; compared to the average of 5.1% of the nurses' counterparts who do not work in healthcare. High incidences of depression and depressive symptoms were also reported in studies among Chinese nurses (38%) and Taiwanese nurses (27.7%). In the Taiwanese study the occurrence of depression was significantly and positively correlated to job stress experienced by the nurses (p<0.001).In a multivariate logistic regression, Ohler, Kerr and Forbes also found that job stress was significantly correlated to depression in nurses. The researchers reported that nurses who experienced a higher degree of job stress were 80% more likely to have suffered a major depressive episode in the previous year. A further finding in this study revealed that 75% of the participants also suffered from at least one chronic disease revealing a strong association between depression and other major health issues.A stressful working environment, such as a hospital, could potentially lead to lateral violence among nurses. Lateral violence is a serious occupational health concern among nurses as evidenced by extensive research and literature available on the topic. The impact of lateral violence has been well studied and documented over the past three decades. Griffin and Clark state that lateral violence is a form of bullying grounded in the theoretical framework of the oppression theory. The bullying behaviors occur among members of an oppressed group as a result of feeling powerless and having a perceived lack of control in their workplace. Griffin identified the ten most common forms of lateral violence among nurses as "non-verbal innuendo, verbal affront, undermining activities, withholding information, sabotage, infighting, scape-goating, backstabbing, failure to respect privacy, and broken confidences". Nurse-to-nurse lateral violence leads to negative workplace relationships and disrupts team performance, creating an environment where poor patient outcomes, burnout and high staff turnover rates are prevalent.Work-related stressors have been indicated as a potential cause of lateral violence. According to the Effort Reward Imbalance model (ERI) developed by Siegrist, work stress develops when an imbalance exists between the effort individuals put into their jobs and the rewards they receive in return. The ERI model has been widely used in occupational health settings based on its predictive power for adverse health and well-being outcomes. The model claims that both high efforts with low rewards could lead to negative emotions in the exposed employees. Vegchel, van Jonge, de Bosma & Schaufeli state that, according to the ERI model, occupational rewards mostly consist of money, esteem and job security or career opportunities. A survey conducted by Reineck & Furino indicated that registered nurses had a very high regard for the intrinsic rewards of their profession but that they identified workplace relationships and stress issues as some of the most important contributors to their frustration and exhaustion. Hauge, Skogstad & Einarsen state that work-related stress further increases the potential for lateral violence as it creates a negative environment for both the target and the perpetrator.Mindfulness based programs have proven to be a promising intervention in reducing stress experienced by nurses. Mindfulness was originally defined by Jon Kabat-Zinn in 1979 as "paying attention on purpose, in the present moment, and nonjudgmentally, to the unfolding of experience moment to moment". The Mindfulness Based Stress Reduction (MBSR) program is an educationally based program that focuses on training in the contemplative practice of mindfulness. It is an eight-week program where participants meet weekly for two-and-a-half hours and join a one-day long retreat for six hours. The program incorporates a combination of mindfulness meditation, body awareness and yoga to help increase mindfulness in participants. The practice is meant to facilitate relaxation in the body and calming of the mind by focusing on present-moment awareness. The program has proven to be effective in reducing stress, improving quality of life and increasing self-compassion in healthcare professionals.Researchers have demonstrated that mindfulness interventions can effectively reduce stress, anxiety and depression in both clinical and non-clinical populations. In a meta-analysis of seven studies conducted with healthy participants from the general public, the reviewers reported a significant reduction in stress when the treatment and control groups were compared. However, there have been limited studies to date that focused specifically on the effectiveness of mindfulness programs to reduce stress experienced by nurses.In addition to stress reduction, mindfulness based interventions can also enhance nurses' capacity for focused attention and concentration by increasing present moment awareness. Mindfulness techniques can be applied in everyday situations as well as stressful situations. According to Kabat-Zinn, work-related stress influences people differently based on their viewpoint and their interpretation of the situation. He states that individuals need to be able to see the whole picture, have perspective on the connectivity of all things and not operate on automatic pilot to effectively cope with stress. The goal of mindfulness meditation is to empower individuals to respond to situations consciously rather than automatically.Prior to the commencement of this systematic review, the Cochrane Library and JBI Database of Systematic Reviews and Implementation Reports were searched. No previous systematic reviews on the topic of reducing stress experienced by nurses through mindfulness programs were identified. Hence, the objective of this systematic review is to evaluate the best research evidence available pertaining to mindfulness-based programs and their effectiveness in reducing perceived stress among nurses.

INTRODUCTION: Graduate healthcare students experience significant stressors during professional training. Mindfulness-Based Stress Reduction (MBSR) is a behavioural intervention designed to teach self-regulatory skills for stress reduction and emotion management. This study examines the impact of MBSR training on students from five healthcare graduate programs in a quasi-experimental trial. METHODS: A total of 13 students completed the MBSR program and were compared with 15 controls. Both groups answered validated questionnaires measuring anxiety, burnout and empathy at baseline, at conclusion of the course (week 8) and 3 weeks post-course completion (week 11). RESULTS: Significant decrease in anxiety at weeks 8 and 11 compared with baseline (P<0.001 and P<0.01, respectively) was observed using the Burns Anxiety Inventory. Significant increase in empathy at week 8 (P<0.0096) was observed using the Jefferson Scale of Physician Empathy. Week 11 demonstrated a decrease in empathy from baseline (not statistically significant) across all subjects. No significant differences in burnout scores at weeks 8 and 11 were observed between those in the intervention and control groups. CONCLUSIONS: These results provide supportive evidence of MBSR as a behavioural intervention to reduce anxiety and increase empathy among graduate healthcare students.

METHODS: Six electronic databases were searched for relevant studies from 2000 to 2019. Forty-one eligible studies were identified. RESULTS: Findings suggest that the people with disabilities' choice to seek healthcare services or not, as well as the quality of intervention provided by primary healthcare providers, are influenced by three types of barriers: cultural beliefs or attitudinal barriers, informational barriers, and practical or logistical barriers. CONCLUSION: In order to achieve full health coverage at acceptable quality for people with disabilities, it is necessary not only to consider the different barriers, but also their combined effect on people with disabilities and their households. It is only then that more nuanced and effective interventions to improve access to primary healthcare, systematically addressing barriers, can be designed and implemented.IMPLICATIONS FOR REHABILITATIONPeople with disabilities in both high income and low- and middle-income country settings are more likely to experience poorer general health than people without disabilities.Barriers to accessing primary healthcare services for people with disabilities result from a complex and dynamic interacting system between attitudinal and belief system barriers, informational barriers, and practical and logistical barriers.Given primary healthcare is often the initial point of contact for referral to specialty care and rehabilitation services, it is crucial for people with disabilities to access primary healthcare services in order to get appropriate referrals for such services, specifically rehabilitation as appropriate.To achieve full health coverage at acceptable quality for people with disabilities, starting with primary healthcare, it is necessary for healthcare stakeholders, including rehabilitation professionals, to consider the combined and cumulative effects of the various barriers to healthcare on people with disabilities and their families and develop an understanding of how healthcare decisions are made by people with disabilities at the personal and the household level.

The purpose of this qualitative case study was to further investigate the work of master and novice clinicians within the practice setting. The sample consisted of three master clinicians and three novice clinicians practicing in orthopedic outpatient physical therapy settings in three different regions of the United States. Data collection by three researchers included observation of each clinician treating at least three patients, audiotaping of all treatment sessions, interviews with clinicians and patients, and a review of patient records. Analysis of the data within and across cases revealed five attribute dimensions that distinguished the master clinician from the novice clinician. One attribute dimension (ie, confidence in predicting patient outcomes) related to knowledge, and four attribute dimensions (ie, ability to control the environment, evaluation and use of patient illness and disease data, focus of verbal and nonverbal communication with patients, and importance of teaching to hands-on care) related to improvisational performance. Further investigations are needed to confirm these findings and add to the body of knowledge concerning the parameters of physical therapy that may affect the efficacy and quality of patient care.

This perspective shares recommendations that draw from (1) the National Study of Excellence and Innovation in Physical Therapist Education research findings and a conceptual model of excellence in physical therapist education, (2) the Carnegie Foundation's Preparation for the Professions Program (PPP), and (3) research in the learning sciences. The 30 recommendations are linked to the dimensions described in the conceptual model for excellence in physical therapist education: Culture of Excellence, Praxis of Learning, and Organizational Structures and Resources. This perspective proposes a transformative call for reform framed across 3 core categories: (1) creating a culture of excellence, leadership, and partnership, (2) advancing the learning sciences and understanding and enacting the social contract, and (3) implementing organizational imperatives. Similar to the Carnegie studies, this perspective identifies action items (9) that should be initiated immediately in a strategic and systematic way by the major organizational stakeholders in physical therapist education. These recommendations and action items provide a transformative agenda for physical therapist education, and thus the profession, in meeting the changing needs of society through higher levels of excellence.

Pharmacist recommendations and their clinical and economic outcomes in a Veterans Affairs (VA) medical center were studied. The first 600 pharmacist recommendations that met study criteria were evaluated for type and frequency, rate of acceptance by physicians, potential benefit or harm, and economic consequences. The study site included inpatient and outpatient settings and a skilled-nursing facility. The most frequent types of pharmacist recommendations involved adjusting the dosage or frequency of administration and discontinuing a drug that was not indicated for the patient's medical problem. The rate of acceptance of the recommendations was 92%. The recommendations led to improved clinical outcomes in over 30% of cases in each setting and no change in over 40% of cases in each setting. Evaluators determined that patient harm was avoided by the recommendations in 90% of cases; patient harm was caused in less than 1% of cases. The overall mean cost avoidance per recommendation was $700, and the mean total cost avoidance for all 600 recommendations was $420,155. Pharmacist recommendations improved clinical outcomes and saved money at a VA medical center.

IMPORTANCE: Aromatase inhibitors (AI) are associated with significant urogenital atrophy, affecting quality of life and drug compliance. OBJECTIVE: To evaluate safety of intravaginal testosterone cream (IVT) or an estradiol-releasing vaginal ring (7.5 μg/d) in patients with early-stage breast cancer (BC) receiving an AI. Intervention was considered unsafe if more than 25% of patients had persistent elevation in estradiol (E2), defined as E2 greater than 10 pg/mL (to convert to pmol/L, multiply by 3.671) and at least 10 pg/mL above baseline after treatment initiation on 2 consecutive tests at least 2 weeks apart. DESIGN, SETTING, AND PARTICIPANTS: Postmenopausal (PM) women with hormone receptor (HR)-positive stage I to III BC taking AIs with self-reported vaginal dryness, dyspareunia, or decreased libido were randomized to 12 weeks of IVT or an estradiol vaginal ring. Estradiol was measured at baseline and weeks 4 and 12 using a commercially available liquid chromatography and tandem mass spectrometry assay; follicle-stimulating hormone levels were measured at baseline and week 4. Gynecologic examinations and sexual quality-of-life questionnaires were completed at baseline and week 12. This randomized noncomparative design allowed safety evaluation of 2 interventions concurrently in the same population of patients, reducing the possibility of E2 assay variability over time and between the 2 interventions. MAIN OUTCOMES AND MEASURES: The primary objective of this trial was to evaluate safety of IVT or an estradiol vaginal ring in patients with early-stage BC receiving an AI; secondary objectives included evaluation of adverse events, changes in sexual quality of life using the Cancer Rehabilitation Evaluation System sexuality subscales, changes in vaginal atrophy using a validated 4-point scale, and comparison of E2 levels. RESULTS: Overall, 76 women signed consent (mean [range] age, 56 [37-78] years), 75 started treatment, and 69 completed 12 weeks of treatment. Mean (range) baseline E2 was 20 (<2 to 127) pg/mL. At baseline, E2 was above the postmenopausal range (>10 pg/mL) in 28 of 76 women (37%). Persistent E2 elevation was observed in none with a vaginal ring and in 4 of 34 women (12%) with IVT. Transient E2 elevation was seen in 4 of 35 (11%) with a vaginal ring and in 4 of 34 (12%) with IVT. Vaginal atrophy and sexual interest and dysfunction improved for all patients. CONCLUSIONS AND RELEVANCE: In PM women with early-stage BC receiving AIs, treatment with a vaginal ring or IVT over 12 weeks met the primary safety end point. Baseline elevation in E2 was common and complicates this assessment. Vaginal atrophy, sexual interest, and sexual dysfunction were improved. Further study is required to understand E2 variability in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00698035.