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To compare the performance of anchor-based methods for estimating thresholds of meaningful within-patient change (i.e., individual change) of clinical outcome assessments in conditions reflecting data characteristics of small- to medium-sized clinical trials.Datasets were generated from the joint distributions of the PROMIS PF 20a T-score changes and a seven-point global change anchor measure. The 108 simulation conditions (1000 replications per condition) included combinations of three marginal distributions of T-score changes, three improvement percentages in the anchor measure, four levels of responsiveness correlations, and three sample sizes. Threshold estimation methods included mean change, median change, ROC curve, predictive modeling, half SD, and SEM. Relative bias, precision, accuracy, and measurement significance of the estimates were evaluated based on comparison with true thresholds and IRT-based individual reliable changes of PROMIS scores. Quantile regression models were applied to select and interpret effects of simulation conditions on estimation bias.When PROMIS T-score changes were distributed normally, the predictive modeling method performed best with 50% or more responders identified by the anchor; the mean and median methods were preferred with 30% responders. For skewed distributions, the median method and ROC method gained more advantages. Among the evaluated study conditions, the improvement percentage condition had the most obvious effects on estimation bias.To establish accurate and precise thresholds, clinical researchers are recommended to prioritize study designs with at least 50% anchor-defined responders and strongly responsive target endpoints with highly reliable scoring calibration and to select optimal anchor-based methods given the data characteristics.

STUDY OBJECTIVES: The Nocturia Sleep Quality Scale (NSQS), a novel patient-reported outcomes measure, was developed to assess the impact of sleep disturbance from nocturia. The objective of this study was to assess the psychometric properties of the NSQS, including its structure, reliability, and validity. METHODS: Data were collected in the context of a web-based, prospective, longitudinal, observational study. Participants with nocturia were randomized 1:1 to either a group that received sleep hygiene instructions, including instructions to limit liquids at nighttime and empty bladder prior to bedtime, or one that did not receive sleep instructions. All participants were asked to provide responses to the web-based questionnaires from day 1 to day 10. Psychometric analyses, aligned with current regulatory guidance, were conducted to evaluate the daily scores and 3-day average scores of NSQS items and potential composites. Item-level analyses were conducted first, followed by composite-level analyses. RESULTS: The NSQS items and supporting measures demonstrated very slight improvement in patient-perceived sleep disturbance from nocturia over the course of the study. NSQS test-retest reliabilities were generally satisfactory. Correlations between NSQS items and related patient-reported measures tended to support the construct validity of the NSQS, and the known-groups analyses supplied evidence of its discriminating ability. NSQS responsiveness statistics were small. CONCLUSIONS: The NSQS is a reliable and valid measure of the impact of nocturia on patients’ sleep. The present analyses lay the psychometric groundwork for the use of the NSQS in future clinical trials to support product approval and labeling claims. CITATION: Williams V, Qin S, Romano CD, et al. Psychometric evaluation of the Nocturia Sleep Quality Scale based on data from a prospective observational study. J Clin Sleep Med. 2021;17(4):691–701.

In 2021, there were 488 incident cases of heat stroke and 1,864 incident cases of heat exhaustion among active component service members of the U.S. Armed Forces. The unadjusted annual rates of incident heat stroke and heat exhaustion peaked in 2018 and then declined in 2019 and 2020. Between 2020 and 2021, the rate of incident heat stroke was relatively stable (0.37 cases per 1,000 person-years [p-yrs]) while the rate of heat exhaustion increased slightly (1.40 cases per 1,000 p-yrs). In 2021, subgroup-specific rates of incident heat stroke and heat exhaustion were highest among male service members, those less than 20 years old, Marine Corps and Army members, recruit trainees, and those in combat-specific occupations. During 2017–2021, a total of 312 heat illnesses were documented among service members in the U.S. Central Command (CENTCOM) area of responsibility (AOR); 6.4% (n=20) were diagnosed as heat stroke. Commanders, small unit leaders, training cadre, and supporting medical personnel must ensure that the military members whom they supervise and support are informed about the risks, preventive countermeasures, early signs and symptoms, and first-responder actions related to heat illnesses.

Osteoarthritis (OA) is the most common adult joint disease and accounts for significant morbidity burdens among U.S. civilian and military populations. During 2016-2020, the crude overall rates of incident OA and spondylosis diagnoses among U.S. active component service members were 630.9 per 100,000 person-years (p-yrs) and 958.2 per 100,000 p-yrs, respectively. Crude annual rates of both conditions decreased markedly from 2016 through 2020 with declines evident in all of the demographic and military subgroups examined. Compared to their respective counterparts, crude overall rates of OA diagnoses were highest among male service members, those aged 35 or older, non-Hispanic Black service members, Army members, and those working in health care occupations. Crude overall rates of spondylosis diagnoses were highest among those aged 30 or older, non-Hispanic White and non-Hispanic Black service members, Army members, and those in health care and communications/intelligence occupations. More than two-thirds of all incident OA diagnoses involved the knee (38.8%) or shoulder (28.4%). Differences in anatomic site-specific rates of OA were apparent by sex, race/ethnicity group, service, and military occupation. Additional research to identify military-specific equipment and activities that increase the risk of acute and chronic damage to joints would be useful to develop, test, and implement practical and effective countermeasures against OA and spondylosis among military members in general and those in high-risk occupations specifically.

Breast cancer continues to be the leading cause of cancer in women in the US, so it is important to provide these women with good therapies. However, there are adverse effects to these therapies. Physical activity plays an important role in alleviating these adverse effects of breast cancer therapy. However, the effectiveness of home-based physical activity interventions such as walking programs has not been detailed by prior reviews. This article reviews articles published to date to examine whether home-based physical activity interventions are effective in improving physical activity and other outcomes among breast cancer patients who are undergoing primary therapy for the disease. The present review is based upon bibliographic searches in PubMed and CINAHL and relevant search terms. Articles published in English from 1980 through February 28, 2019 were identified. A total of 360 article citations were identified in PubMed and non-duplicates in CINAHL. After screening the abstracts or full texts of these articles and reviewing the references of previous review articles, we found 15 studies that met the eligibility criteria. Four of the studies were pre/post-test trials, 10 were randomized controlled trials, and one study was an observational study. Results from studies published to date indicate that among women receiving primary breast cancer therapy, home-based physical activity programs have positive effects on physical functioning and symptoms such as fatigue. Among women receiving adjuvant chemotherapy or radiation therapy, home-based physical activity programs are effective in reducing symptoms and improving physical functioning. Additional studies are needed to clarify the impact of home-based physical therapy interventions on other outcomes including quality-of-life, bone mineral density, cognitive functioning, and chemotherapy-induced peripheral neuropathy.

Background/objective Nocturia's impact on sleep causes significant burden for patients. This study aimed to develop a novel patient-reported outcome (PRO) measure, the Nocturia Sleep Quality Scale (NSQS), for the assessment of the impact of nocturia (defined as ≥2 nocturnal voids/night) on sleep. Methods Sleep-related concepts were identified through a targeted literature review, after which in-depth concept elicitation interviews with patients with a clinical diagnosis of nocturia were conducted. Draft items were generated to address concepts identified as important, meaningful, and relevant. Items were further refined through three iterative sets of cognitive debriefing interviews to optimize instructions, question wording, and response options. Two sleep research experts also provided input. Results The literature review and data from 18 concept elicitation interviews provided the basis for a comprehensive set of concepts. Constant comparative analysis was used to identify themes and support item development. The draft questionnaire consisted of 14 items with item-specific response scales. Wording and scaling of the items was optimized based on feedback from the 22 cognitive debriefing interviews and expert input. The results confirmed the completeness and relevance of the NSQS, providing support for the content validity and ability of items to reflect patient perception of nocturia-related sleep impacts. Conclusions The 6-item NSQS assesses the impact of nocturia on sleep by evaluating nighttime awakenings, sleep quantity, and sleep quality. The NSQS is self-administered and is intended to assess change in nocturia's impact on sleep after treatment in a standardized manner. Psychometric evaluation is under way to describe key measurement properties.

Background Vulvovaginal candidiasis (VVC) is a common infection affecting women worldwide. Reports of patterns/risk factors/trends for episodic/recurrent VVC (RVVC) are largely outdated. The purpose of this study was to obtain current patient perspectives of several aspects of VVC/RVVC. Methods Business cards containing on-line survey information were distributed to healthy volunteers and patients seeking standard, elective, or referral gynecologic care in university-affiliated Obstetrics/Gynecology clinics. The internet-based questionnaire was completed by 284 non-pregnant women (78% Caucasian, 14% African American, 8% Asian). Results The majority of the participants (78%) indicated a history of VVC with 34% defined as having RVVC. The most common signs/symptoms experienced were itching, burning and redness with similar ranking of symptoms among VVC and RVVC patients. Among risk factors, antibiotic use ranked highest followed by intercourse, humid weather and use of feminine hygiene products. A high number of respondents noted ‘no known cause’ (idiopathic episodes) that was surprisingly similar among women with a history of either VVC or RVVC. VVC/RVVC episodes reported were primarily physician-diagnosed (73%) with the remainder mostly reporting self-diagnosis and treating with over-the-counter (OTC) medications. Most physician-diagnosed attacks utilized a combination of pelvic examination and laboratory tests followed by prescribed antifungals. Physician-treated cases achieved a higher level of symptom relief (84%) compared to those who self-medicated (57%). The majority of women with RVVC (71%) required continual or long-term antifungal medication as maintenance therapy to control symptoms. Conclusions Current patient perspectives closely reflect historically documented estimates of VVC/RVVC prevalence and trends regarding symptomatology, disease management and post-treatment outcomes. Electronic supplementary material The online version of this article (10.1186/s12905-019-0748-8) contains supplementary material, which is available to authorized users.

The Impact of Weight on Quality of Life–Lite Clinical Trials Version (IWQOL-Lite-CT) was developed to assess weight-related physical and psychosocial functioning in the context of clinical trials. Data from two pivotal trials of once-weekly subcutaneous semaglutide for the purpose of weight management (NCT03548935 and NCT03552757) were analysed to confirm the structure, reliability, validity, and responsiveness of the IWQOL-Lite-CT and evaluate the magnitude of meaningful within-patient change in patients with overweight or obesity, with and without type 2 diabetes. Factor analyses and inter-item correlations confirmed the IWQOL-Lite-CT structure and scoring algorithm. Each composite score (physical, physical function, psychosocial, and total) demonstrated excellent internal consistency (Cronbach's alphas ≥ 0.82) and test–retest reliability (intraclass correlation coefficients ≥ 0.85) in both trials. Patterns of cross-sectional and longitudinal construct validity correlations were generally consistent with hypotheses. Each of the IWQOL-Lite-CT composites was able to discriminate between known groups. Effect sizes and paired t tests comparing IWQOL-Lite-CT scores at baseline and Week 68 were statistically significant for all composites in both trials (P

Scholars consider Mary Wollstonecraft an early feminist political theorist for two reasons: (1) her explicit commitment to educational equality, and (2) her implicit suggestion that the private‐sphere role of motherhood holds political import. My reading of Wollstonecraft's A Vindication of the Rights of Womanuses Wollstonecraft's works and draws upon recent claims made by Sandrine Bergès inThe Social and Political Philosophy of Mary Wollstonecraft to connect these points: educated women are better at performing motherly duties and, therefore, of greater benefit to society. Although many scholars have read Wollstonecraft's arguments for educational equality as a starting point for greater equality, Bergès does not. In this article, I further Bergès's claims and argue that Wollstonecraft's project is limited and likely to reinforce inequality between the sexes. Specifically, I show that Wollstonecraft's educational reforms incentivize women to become nothing more than highly educated housewives. In the process of fulfilling their social and political duty to instill public spirit and private virtue in future citizens, women are re‐entrenched in domestic affairs instead of being freed for public pursuits. This realization, I contend, should cause us to be wary of panaceas for women's subordination that rest on increasing their education.

Most research about experiences considering and seeking abortion comes from women presenting at abortion clinics. This study examines experiences among women presenting at prenatal care. Five hundred eighty-nine women were recruited at their first prenatal visit in Southern Louisiana and Baltimore, Maryland. Participants completed self-administered iPad surveys and in-clinic structured interviews. Participants were asked if they had considered abortion for this pregnancy and, if so, reasons they did not obtain one. Twenty-eight percent of Louisiana and 34% of Maryland participants had considered abortion. Ten percent in Louisiana and 13% in Maryland had called an abortion clinic; 2% in Louisiana and 3% in Maryland had visited an abortion clinic. The most common reason for not having an abortion related to women’s own decision-making, i.e. their personal preferences. Policy-related reasons were less common; but more participants who had considered abortion in Louisiana than Maryland reported a policy-related reason (primarily lack of funding for the abortion) as a reason (22% Louisiana, 2% Maryland, p

Introduction Several studies have provided important information about health conditions and other challenges faced by women diagnosed with breast cancer and how they can improve their quality of life and reduce their risk of cancer recurrence. Although African American and Hispanic breast cancer patients have a poorer survival than their white counterparts, few studies have compared the experiences of African American, Hispanic, and non-Hispanic white breast cancer survivors. Objectives To facilitate collaborative studies on breast cancer survivorship in a multicultural population, including future intervention research on nutrition, and physical activity, and clinical substudies. Methods This cohort study consists of a postal survey of up to 1,000 women with a history of a breast cancer diagnosis who reside in Augusta-Richmond County, Georgia, USA, and a repeat survey in 4 to 5 years to obtain longitudinal data. The follow-up survey in 4 to 5 years will allow for longitudinal changes in health to be assessed. Conclusion The survey will provide a comprehensive picture of the health of breast cancer survivors, across the lifespan, in a large Southern city. A broad range of health issues will be addressed including physical activity, diet, nutrition, personal and family history of cancer, quality-of-life, psychosocial concerns, and beliefs about cancer recurrence risk reduction through lifestyle changes. Through its longitudinal design, the study will also provide important information about changes in physical and mental health as breast cancer survivors advance in age.

This study describes cigarette smoking trajectories, the influence of social smoker self-identification (SSID), and correlates of these trajectories in two cohorts of U.S. young adults: a sample from the Chicago metropolitan area (Social Emotional Contexts of Adolescent and Young Adult Smoking Patterns [SECAP], n = 893) and a national sample (Truth Initiative Young Adult Cohort Study [YA Cohort], n = 1,491). Using latent class growth analyses and growth mixture models, five smoking trajectories were identified in each sample: in SECAP: nonsmoking ( n = 658, 73.7%), declining smoking ( n = 20, 2.2%), moderate/stable smoking ( n = 114, 12.8%), high/stable smoking ( n = 79, 8.9%), and escalating smoking ( n = 22, 2.5%); and in YA Cohort: nonsmoking ( n = 1,215, 81.5%), slowly declining smoking ( n = 52, 3.5%), rapidly declining smoking ( n = 50, 3.4%), stable smoking ( n = 139, 9%), and escalating smoking ( n = 35, 2.4%). SSID was most prevalent in moderate/stable smoking (35.5% SECAP), rapidly declining smoking (25.2% YA Cohort), and nonsmoking. Understanding nuances of how smoking identity is formed and used to limit or facilitate smoking behavior in young adults will allow for more effective interventions to reduce tobacco use.

The objective of this study was to assess the current use of patient-centered psychosocial assessments for the evaluation of children with central precocious puberty (CPP). Studies evaluating the psychosocial impact of CPP were identified through searches of the PubMed and Cochrane Library databases, ClinicalTrials.gov, a drug prescribing information database, and regulatory websites. Studies were screened using prespecified inclusion and exclusion criteria. Potentially relevant patient-centered outcome assessments (including patient-, parent- or observer-reported measures) used in the identified studies were evaluated in detail for their relevance in CPP. Of the 467 studies identified, 15 met the inclusion criteria. Frequently assessed concepts included depression and anxiety, behavior and behavioral problems, body image and self-esteem and personality type/characteristics. Among the assessments used in the identified studies, the Child Behavior Checklist, Pediatric Quality of Life Inventory (PedsQL), SF-10 for Children and Child Health Questionnaire were comprehensively evaluated. The PedsQL showed promise as a patient-centered outcome measure in CPP. Although there is a lack of validated tools measuring psychosocial health and health-related quality of life in patients with CPP, the PedsQL captures issues seen in this patient population and is relatively easy to administer. Further studies using this and other tools in children with CPP are needed.

James F Donohue,1 Vamsi K Bollu,2 Donald E Stull,3 Lauren M Nelson,4 Valerie SL Williams,4 Michael D Stensland,5 Nicola A Hanania6 1Department of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, 2Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Princeton, NJ, 3Data Analytics and Design Strategy, 4Psychometrics, RTI Health Solutions, Research Triangle Park, NC, 5Agile Outcomes Research, Inc., Rochester, MN, 6Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of arformoterol on HRQoL in COPD patients, measured by St George’s Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized arformoterol 15µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results: SGRQ Total score improved by 4.24 points with arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P

Purpose Young adulthood is an important period for preventing the establishment of negative health behaviors that can influence trajectories to chronic disease and early death. Given the evolving nature of educational attainment and income variation during this developmental period, identifying indicators of socioeconomic status (SES) remains a challenge. This study examines measures of subjective and objective indicators of SES to predict health risk for young adults. Methods This study uses data from the Truth Initiative Young Adult Cohort Study from respondents aged 18 to 34 years who completed 3 consecutive surveys between June 2011 and August 2012 (n = 2182). Analyses were conducted to compare a measure of subjective financial situation (SFS) to commonly used SES measures for adults and adolescents. Age-stratified, multivariable logistic regression was used to model the relationship between 5 SES indicators (SFS, household income, respondent education, parental education, and subjective childhood financial situation) and dichotomized versions of 3 health status measures (body mass index, self-reported health status, and quality of life), controlling for gender, race/ethnicity, and region. Results Findings indicate that SFS is associated with other commonly used SES measures. Prospective associations with health outcomes revealed that SFS is a stronger predictor of health outcomes among young adults aged 18 to 24 years as compared with other SES measures. Conclusion This study provides evidence that subjective financial situation may be more robust than traditional SES indicators in predicting health outcomes among young adults, particularly for 18- to 24-year-olds, and should be considered a viable candidate measure for assessing SES among this age group.

The phenomenon of “social smoking” emerged in the past decade as an important area of research, largely due to its high prevalence in young adults. The purpose of this study was to identify classes of young adult ever smokers based on measures of social and contextual influences on tobacco use. Latent class models were developed using social smoking measures, and not the frequency or quantity of tobacco use. Data come from a national sample of young adult ever smokers aged 18–24 (Truth Initiative Young Adult Cohort Study, N = 1,564). The optimal models identified three latent classes: Class 1 – Nonsmokers (52%); Class 2 – Social smokers (18%); and Class 3 – Smokers (30%). Nearly 60% of the “social smoker” class self-identified as a social smoker, 30% as an ex-smoker/tried smoking, and 12% as a non-smoker. The “social smoker” class was most likely to report using tobacco mainly or only with others. Past 30-day cigarette use was highest in the “smoker” class. Hookah use was highest in the “social smoker” class. Other tobacco and e-cigarette use was similar in the “social smoker” and “smoker” classes. Past 30-day tobacco and e-cigarette use was present for all products in the “non-smoker” class. Young adult social smokers emerge empirically as a sizable, distinct class from other smokers, even without accounting for tobacco use frequency or intensity. The prevalence of hookah use in “social smokers” indicates a group for which the social aspect of tobacco use could drive experimentation and progression to regular use.

There is limited research on the impact of antidepressant treatment on family functioning. This study examines the impact of vortioxetine and agomelatine on family functioning using the Depression and Family Functioning Scale (DFFS).The DFFS was included in REVIVE, a randomized, double-blind study of adults with major depressive disorder with inadequate response to antidepressant treatment who switched to vortioxetine or agomelatine. The prespecified DFFS analyses were performed using change from baseline to weeks 8 and 12, analyzed by mixed models for repeated measurements by treatment groups. Post hoc analyses compared DFFS scores for remitters and nonremitters. Patients were stratified into quartiles using DFFS scores, and scores on other clinical outcome assessments were compared.Sizeable improvements in DFFS scores were observed from baseline to week 8 (-10.8, -7.9 for vortioxetine and agomelatine, respectively), with further improvements at week 12 (-13.5, -11.0). Vortioxetine (n = 189) was superior to agomelatine (n = 187) by 2.9 DFFS points at week 8 (p .01) and 2.5 points at week 12 (p .05), and DFFS item-level improvements were also significantly greater for vortioxetine for 8 of 15 DFFS items at week 8 and 7 items at week 12. At week 8, remitters (n = 142) and nonremitters (n = 233) differed by 11 DFFS points; at week 12, remitters (n = 183) and nonremitters (n = 121) differed by almost 12 DFFS points. Patients stratified into baseline DFFS quartiles showed trends on clinical outcomes such that better family functioning was associated with better functional status and depressive symptoms.Vortioxetine was significantly superior to agomelatine in terms of family functioning and partner relationships, as well as social functioning, health status, and depression symptoms at weeks 8 and 12. Depressed patients with impaired family functioning showed worse overall functioning, health status, and depression symptoms, suggesting that more attention should be given to family functioning of depressed patients.

Purpose States have enacted an increasing number of policies restricting access to abortion. As a result, some women are unable to obtain an abortion and instead continue their pregnancies. These women may have particular needs that would bring them to the attention of public health programs. Methods Pregnant women entering prenatal care completed a self-administered survey and structured interview at four prenatal facilities in Louisiana and Maryland (N = 586). Participants reported their pregnancy intentions, whether they had considered abortion, and their reasons for not having an abortion (e.g., personal reasons, policy barriers to care). Participants completed up to 13 items indicating their service needs; an index was created by summing across nine common items. Data were analyzed through descriptive statistics, bivariate analyses, and multivariable regression models that controlled for sociodemographic characteristics. Results On average, women reported 2.99 service needs. The most common needs were WIC (93%), food stamps (85%), dental care (59%), and housing assistance (53%). In multivariable analyses, women who considered abortion but did not face a policy barrier reported greater service needs compared to women who did not consider abortion (3.45 vs. 2.82; b = 0.64; 95% confidence interval, 0.25–1.04). Women reporting a policy barrier to abortion reported the highest service needs (3.95) of all groups, although differences were not statistically significant possibly owing to sample size. Conclusions Pregnant women who consider abortion before entering prenatal care have considerable health and social service needs. Public health programs that serve women and children should consider the specific needs of women who seek abortions.

The AMCP Managed CareSpecialty Pharmacy Annual Meeting 2019 in San Diego, California, is expected to attract more than 4,000 managed care pharmacists and other health care professionals who manage and evaluate drug therapies, develop and manage networks, and work with medical managers and information specialists to improve the care of all individuals enrolled in managed care programs. The AMCP Abstracts program provides a forum through which authors can share their insights and outcomes of advanced managed care practice. Poster presentations are scheduled for Wednesday, March 27, from 11:30 am to 1:00 pm. Posters will also be displayed on Tuesday, March 26, from 5:30 pm to 7:00 pm, during the opening night reception in the Expo, and on Thursday, March 28, from 9:30 am to 11:00 am. Podium presentations for the Platinum award-winning abstracts are Tuesday, March 26, from 2:30 pm to 3:45 pm. Professional abstracts that have been reviewed are published in the Journal of Managed CareSpecialty Pharmacy's Meeting Abstracts supplement. Abstracts were submitted in the following categories.

Family Options is a psychiatric rehabilitation intervention for parents with severe mental illness and their children who work with family coaches to set and achieve goals. The objective of this study is to compare changes in well-being, functioning, and supports and resources achieved from enrollment to 12 months by mothers participating in Family Options (N = 22) with changes from enrollment to 6 months. Mothers’ scores are compared on standardized measures of psychological distress, trauma symptom severity, mental and physical health status, social support, and the number of services needed but not received from enrollment to 6 months, and from enrollment to 12 months. Data were also obtained about help received and satisfaction with Family Options. Mothers achieved significant improvements in well-being at 12 months, as measured in terms of reductions in psychological distress and symptom severity scores. Significant improvements in social support and services received were reported at 6 month...

Online data collection has become an extremely popular survey mode given its reduced cost, ease of administration, and timeliness. Although extensive research exists on the influence of e-mail invitation design characteristics to prompt survey participation, less is known about the effectiveness of e-mail reminders in prompting survey completion among nonresponders. The purpose of this study was to determine whether incorporating humor into e-mail reminders improved survey completion rates. Respondents from the Truth Initiative Young Adult Cohort ( n = 2,963) who did not respond to the first standard e-mail invitation to complete their follow-up survey were randomly assigned to one of the three e-mail reminder groups: control (standard), humor only, or humor plus statistics. Those who received an initial humor plus statistics reminder e-mail received the humor only e-mail as their second reminder and vice versa. Logistic regression was used to generate the odds ratios ( OR) for the probability of completing the survey after the first reminder. Results of multivariable models showed that, when collapsed together, the humor only and humor plus statistics e-mails were more effective than the control [adjusted OR (AOR) = 1.23, 95% confidence interval (CI) [1.01, 1.49], p = .05]. Receiving the humorous e-mail as the first reminder increased the odds of response to the survey by 24% (AOR = 1.24, 95% CI [1.00, 1.54], p = .04). Those entering the study at an earlier wave, nonsmokers and those living in smaller households were more likely to respond after the first reminder. A humorous reminder tailored to the voice of the audience is an easy, efficient, and effective way to increase response rates among young adults.

Introduction To assess self-reported physical functioning in patients with sporadic inclusion body myositis (sIBM), the sIBM Physical Functioning Assessment (sIFA) was developed. This research establishes the validity, reliability, and responsiveness of the sIFA in patients with sIBM. Methods Data from 3 small, noninterventional, observational studies were analyzed. Several measures of physical function were included to assess validity. Reliability (Cronbach alpha, test-retest intraclass correlations), construct validity (correlations, analyses of variance), and responsiveness (effect size estimates) were evaluated. Results Cronbach alphas (range = 0.86-0.91) and test-retest reliability (0.91) were highly satisfactory. Correlations with other measures provided evidence of convergent validity. sIBM patients able to walk without assistive devices scored significantly better on the sIFA (means = 36.0-47.05) than those who required power mobility or wheelchairs (means = 54.9-71.5), demonstrating the discriminating ability of the sIFA. Effect size estimates of responsiveness suggested mild functional progression. Conclusions Psychometric analyses of the sIFA demonstrate satisfactory reliability, validity, and responsiveness. Muscle Nerve 54: 658-665, 2016.

The Lens on Climate Change (LOCC) is an informal, place-based science program designed to engage middle and high school students from underserved groups in learning and communicating about impacts of climate change on their communities. This student-driven experience involves identifying a local environmental challenge, researching the topic, and creating a short film about it with the guidance of film and science mentors. The case study presented here provides an in-depth analysis of a small group of Native American high school students whose film depicts a strong connection to place and includes stories about their personal experiences of the impacts of drought on their community. LOCC’s focus on the communities where students live was maintained even when students participated in a workshop outside of their home communities. Even in this unique context for a place-based program, the students drew meaningful connections to home and to a critical environmental challenge that impacted their community through their films and filmmaking processes. Follow-up interviews with the students suggested that the LOCC program experience was transformative for them with regard to their personal actions around environmental challenges and their approaches to thinking and communicating about climate change. LOCC’s focus on place and storytelling through film helped students find greater personal meaning in the geoscience topics they were learning and may be a useful model for other education programs in geoscience. The alignment of LOCC with components of culturally responsive teaching and future directions for tailoring the program for Indigenous students are discussed.

Virtual reality (VR) stories provide an immersive and interactive medium to present narrative content. While it provides an immersive way to present the content, it is challenging to present the story in a way that matches the intention of the producer. There are several aspects of the VR environment that may affect the way the viewer experiences and perceives the content including the inhabited character by the viewer, the available interactive objects, areas of interest in the scene and their salience to receive attention. This presented demonstration is part of a project where we are investigating the ways a VR story can be presented-in other words, how the VR environment can be designed-to provide affordances that will help the viewer to perceive the story as intended by the producer, without explicitly guiding the viewer for particular interactions. Refereed/Peer-reviewed

Introduction: Several studies have provided important information about health conditions and other challenges faced by women diagnosed with breast cancer and how they can improve their quality of life and reduce their risk of cancer recurrence. Although African American and Hispanic breast cancer patients have a poorer survival than their white counterparts, few studies have compared the experiences of African American, Hispanic, and non-Hispanic white breast cancer survivors. Objectives: To facilitate collaborative studies on breast cancer survivorship in a multicultural population, including future intervention research on nutrition, and physical activity, and clinical substudies. Methods: This cohort study consists of a postal survey of up to 1,000 women with a history of a breast cancer diagnosis who reside in Augusta-Richmond County, Georgia, USA, and a repeat survey in 4 to 5 years to obtain longitudinal data. The follow-up survey in 4 to 5 years will allow for longitudinal changes in health to be assessed. Conclusion: The survey will provide a comprehensive picture of the health of breast cancer survivors, across the lifespan, in a large Southern city. A broad range of health issues will be addressed including physical activity, diet, nutrition, personal and family history of cancer, quality-of-life, psychosocial concerns, and beliefs about cancer recurrence risk reduction through lifestyle changes. Through its longitudinal design, the study will also provide important information about changes in physical and mental health as breast cancer survivors advance in age.

Background Professional guidelines indicate that pregnancy options counseling should be offered to pregnant women, in particular those experiencing an unintended pregnancy. However, research on whether pregnancy options counseling would benefit women as they enter prenatal care is limited. This study examines which women might benefit from options counseling during early prenatal care and whether women are interested in receiving counseling from their prenatal care provider. Methods At four prenatal care facilities in Louisiana and Maryland, women entering prenatal care completed a self-administered survey and brief structured interview (N = 586). Data were analyzed through descriptive statistics, bivariate analyses, multivariate multinomial logistic regression, and coding of open-ended responses. Results At entry into prenatal care, most women reported that they planned to continue their pregnancy and raise the child. A subset (3%) scored as having low certainty about their decision on the validated Decision Conflict Scale, indicating need for counseling. In addition, 9% of women stated that they would be interested in discussing their pregnancy options with their prenatal care provider. Regression analyses indicated some sociodemographic differences among women who are in need of or interested in options counseling. Notably, women who reported food insecurity in the prior year were found to be significantly more likely to be in need of options counseling (RRR = 3.20, p

Introduction This study assessed the impact of brief exposure to four electronic cigarette (e-cigarette) print advertisements (ads) on perceptions, intention, and subsequent use of e-cigarettes and cigarettes in US young adults. Methods A randomized controlled trial was conducted in a national sample of young adults from an online panel survey in 2013. Participants were randomized to ad exposure or control. Curiosity, intentions, and perceptions regarding e-cigarettes were assessed post-exposure and e-cigarette and cigarette use at 6-month follow-up. Analyses were conducted in 2014. Results Approximately 6% of young adults who had never used an e-cigarette at baseline tried an e-cigarette at 6-month follow-up, half of whom were current cigarette smokers at baseline. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette (18.3% exposed vs. 11.3% unexposed, AOR = 1.63, 95% CI = 1.18, 2.26) among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up (3.6% exposed vs. 1.2% unexposed, AOR = 2.85; 95% CI = 1.07, 7.61) among never users of cigarettes and e-cigarettes. Exploratory analyses did not find an association between ad exposure and cigarette trial or past 30-day use among never users, nor cigarette use among smokers over time. Curiosity mediated the relationship between ad exposure and e-cigarette trial among e-cigarette never users. Conclusions Exposure to e-cigarette ads may enhance curiosity and limited trial of e-cigarettes in never users. Future studies are needed to examine the net effect of curiosity and trial of e-cigarettes on longer-term patterns of tobacco use. Implications This randomized trial provides the first evidence of the effect of e-cigarette advertising on a behavioral outcome in young adults. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up in a small number of never e-cigarette users and greater likelihood of e-cigarette trial at follow-up among never users of cigarettes and e-cigarettes.

Historically, the assessment of longitudinal construct validity in the field of psychosocial measurement involved defining hypotheses and calculating correlation coefficients using scores based on 2 measures at 2 or more time points. In the context of patient-reported outcomes, this evolved into sensitivity to change and responsiveness, including the computation of effect size estimates of change, standardized response means, and indices such as Guyatt's statistic. Cross-sectional analyses or analyses based on 2 time points have been the standard practice. Evolving conceptualizations have incorporated more than 2 time points and have included depictions of individual trajectories of change in multiple measures, structural equation models, and mixed modeling techniques. The focus of this article is on methods to evaluate longitudinal construct validity. We describe a sample of these methods and provide considerations and recommendations for designing a thoughtful longitudinal construct validity evaluation of clinical outcome assessments.

Objectives To evaluate the psychometric properties of Patient’s Knee Implant Performance Questionnaire (PKIP), a new patient-reported measure of knee implant functional performance assessing patient experiences before and after primary total knee arthroplasty (TKA). Methods The psychometric analysis sample (n = 761) was based on an ongoing, multisite, prospective, noncomparative, longitudinal study of patients undergoing TKA. The PKIP was completed at three study visits: presurgery (visit 1), less than 1 year (visit 3, days 1–303), and minimum 1 year (visit 4, days 304–668). Visit 2 was an operative visit. Supporting outcome measures were collected at each study visit. The PKIP structure and its psychometric properties were assessed as part of a secondary data analysis using an interim data cut before the end of the clinical trial. Results The PKIP includes four subscales (confidence, stability, activity modification, and satisfaction) and an overall PKIP score. The overall PKIP score met internal consistency (visit 4 = 0.79) and test-retest reliability (intraclass correlation coefficient = 0.77) standards. Correlations between the PKIP and other measures (e.g., the American Knee Society score and the Knee Injury and Osteoarthritis Outcome Score) provided evidence of construct validity. The PKIP was capable of discriminating between groups of patients with better or worse knee function. The effect size for the overall PKIP score was 2.96 from baseline to visit 4, indicating that the PKIP was highly responsive. Conclusions The reliability, validity, and responsiveness of the PKIP support its use among patients undergoing TKA.

Introduction Awareness and use of electronic cigarettes has rapidly increased among U.S. adults. The aim of this study was to examine awareness and likeability of e-cigarette print advertisements in a national sample of young adults and to examine ad likeability as a correlate of intended e-cigarette use among never e-cigarette users. Material and Methods Participants (n = 2110, unweighted) of the Truth Initiative Young Adult Cohort (January 2013) were randomized to see four print ads (blu, Fin, NJOY, and White Cloud). Bivariate analyses provided descriptive characteristics of all participants and multivariable logistic regression examined the relationships between the average likeability score (across all four ads), curiosity about e-cigarettes, and susceptibility to using e-cigarettes among respondents who had never used e-cigarettes. Results Nearly 20% of participants reported awareness of the blu ad. Of the four e-cigarette ads, likeability was highest for the NJOY ad. Participants with higher ad likeability ratings had more than twice the odds of being curious to try an e-cigarette (AOR 2.33; 95% CI 1.84–2.95), try an e-cigarette soon (AOR 2.93; 95% CI 1.96–4.38), and try an e-cigarette if offered by best friend (AOR 2.48; 95% CI 1.95–3.15), after adjusting for other covariates. Current cigarette use was the strongest correlate of susceptibility to using an e-cigarette (p

Objectives. We monitored the prevalence and patterns of use of the array of tobacco products available to young adults, who are at risk for initiation and progression to established tobacco use. Methods. We used data from waves 1 to 3 of GfK’s KnowledgePanel (2011–2012), a nationally representative cohort of young adults aged 18 to 34 years (n = 2144). We examined prevalence and patterns of tobacco product use over time, associated demographics, and state-level tobacco policy. We used multivariable logistic regression to determine predictors of initiation of cigarettes as well as noncombustible and other combustible products. Results. The prevalence of ever tobacco use rose from 57.28% at wave 1 to 67.43% at wave 3. Use of multiple products was the most common pattern (66.39% of tobacco users by wave 3). Predictors of initiation differed by product type and included age, race/ethnicity, policy, and use of other tobacco products. Conclusions. Tobacco use is high among young adults and many are using multiple products. Efforts to implement policy and educate young adults about the risks associated with new and emerging products are critical to prevent increased initiation of tobacco use.