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A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group ( n = 32) or a simplified paper-based consent group ( n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study.

The aims of this study were to (1) identify and categorize study eligibility criteria concepts used in cancer nursing randomized controlled trials and (2) determine the extent to which a previously identified set of study eligibility criteria, based primarily on medical randomized controlled trials, were represented in cancer nursing randomized controlled trials. A total of 145 articles of cancer nursing randomized controlled trials indexed in PubMed or Cumulative Index to Nursing and Allied Health Literature and published in English from 1986 to 2010 were screened, and 114 were eligible. Directed content analysis was conducted until data saturation was achieved. Forty-three concepts categorized into eight domains were extracted from 49 articles published in 27 different journals. Most of the concepts identified were related to health status, treatment, and demographics domains. Although many concepts matched to the previously identified study eligibility concepts based on medical research, new concepts may need to be added to fully represent cancer nursing research. This study provides a solid foundation for future study of mapping the concepts to existing standardized terminologies to identify which systems can be adopted. Nursing researchers can use these eligibility criteria concepts as a guideline in structuring the eligibility criteria for their studies.

Monitoring patient-reported symptoms is necessary to adjust and improve supportive care during chemotherapy. Continuing advances in computerized approaches to symptom monitoring can enhance communication about unrelieved symptoms between patients and oncology providers and may facilitate intensified symptom treatment.An automated IT-based telephone monitoring system was developed to enable oncology providers to receive and act on alert reports from patients about unrelieved symptoms during chemotherapy treatment. Daily, 250 participants (randomized to treatment or attentional control) were asked to call the automated system to report presence, severity, and distress for common chemotherapy-related symptoms (1-10 scale if present). For the treatment group, symptoms exceeding preset thresholds for moderate-to-severe intensity levels generated emailed alert reports to both the patient's oncologist and oncology nurse.Patients reported high satisfaction and ease of use of the automated system. Over 80 % of providers reported usefulness of the symptom alert reports. Ten monitored symptoms resulted in, on average, nine moderate-to-severe intensity alerts per patient over 45 study days. However, providers rarely contacted patients after receiving alerts. There were no significant differences in change of symptom severity between the two groups (mean difference = 0.06, p = 0.58).Despite patients' use of a daily symptom monitoring system and providers' receipt of information about unrelieved symptoms of moderate-to-severe intensity, oncology physicians and nurses did not contact patients to intensify symptom treatment nor did symptoms improve. Further research is indicated to determine if oncology providers initiated follow-up to intensify symptom treatment, whether symptom outcomes would improve.

Technology‐aided remote interventions for poorly controlled symptoms may improve cancer symptom outcomes. In a randomized controlled trial, the efficacy of an automated symptom management system was tested to determine if it reduced chemotherapy‐related symptoms. Prospectively, 358 patients beginning chemotherapy were randomized to the Symptom Care at Home (SCH) intervention (n = 180) or enhanced usual care (UC) (n = 178). Participants called the automated monitoring system daily reporting severity of 11 symptoms. SCH participants received automated self‐management coaching and nurse practitioner (NP) telephone follow‐up for poorly controlled symptoms. NPs used a guideline‐based decision support system. Primary endpoints were symptom severity across all symptoms, and the number of severe, moderate, mild, and no symptom days. A secondary endpoint was individual symptom severity. Mixed effects linear modeling and negative binominal regressions were used to compare SCH with UC. SCH participants had significantly less symptom severity across all symptoms (P

Me & My Wishes are facilitated, resident-centered video-recorded conversations to communicate current and end-of-life care preferences. We describe the video production process of two prototypes in the long-term care (LTC) setting and discuss lessons learned around developing this type of intervention. Partnering with an LTC community allowed us to create videos on-site, document staff time, handle any barriers with video production, and evaluate the process. In this article, we will describe the process of two residents creating Me & My Wishes videos. Both residents responded positively to viewing their edited video (about 20 min), saying the videos would be “good for family or staff to hear feelings about preferences.” Staff members also responded positively to the videos. We discuss two key issues to consider: the possibility that resident preferences may change and the resources to produce and view videos.

Agricultural pesticide exposure has potential adverse health effects for farmworkers that may be reduced by pesticide protective behaviors (PPBs). The Environmental Protection Agency’s (EPA) Worker Protection Standard (WPS) requires PPBs be taught to farmworkers prior to field work. Studies to date have not utilized observational methods to evaluate the degree to which PPBs are practiced by Latino migrant and seasonal farmworkers in the United States. The purpose of this study was to describe, compare, and contrast observed and self-reported PPBs used by Latino farmworkers; both PPBs that the WPS requires be taught and other PPBs were included. Observed and self-reported data were collected from 71 Latino farmworkers during the 2014 tobacco growing season in North Carolina. Participants were consistent in reporting and using long pants and closed shoes in the field most of the time. In addition, gloves, hats/bandanas, and water-resistant outerwear were frequently observed, although they are not required to be taught by the WPS. Farmworkers reported more long-sleeve (p = .028) and glove use (p = .000) than what was observed. It was uncommon to observe washing behavior before eating or drinking, even when washing supplies were available. Washing behaviors were significantly overreported for hand (p = .000; (p = .000) and face (p = .000; (p = .058) washing before eating and drinking in the field. This study documents that protective clothing behaviors that the WPS requires be taught, plus a few others are commonly practiced by Latino migrant and seasonal farmworkers, but washing behaviors in the field are not. Targeted strategies to improve washing behaviors in the field are needed.

This paper discusses attitudes and opinions of a diverse group of participants toward the retention and use of residual newborn blood samples for research. Data were drawn from focus groups based in six states in the USA, and results provide support for the retention and use of residual newborn blood samples for research when parental permission is asked beforehand. However, there were a number of concerns that also warrant attention for the development of policy and maintaining trust with the public, such as timing of permission, use of samples already stored, level of personal control of sample use and education. The results demonstrate the complexity of the topic and the ethical ambiguities associated with the retention and use of residual newborn blood samples.

Background This prospective descriptive study examined the relationship between low-tech, high-fidelity simulation–based training and pre- and posttraining changes in participant self-efficacy (SE). Method A 3-week training was followed by a 2-day session 4 months later in Cuernavaca, Mexico. Midwives and obstetrical nurses either participated in or observed 41 scenarios during a clinical update in emergency obstetric skills. Results SE increased significantly. It decreased at 4 months posttraining but remained higher than pretraining levels. Conclusion The training positively affected participants' perceived readiness for the technical, behavioral, and cognitive dimensions of obstetric emergencies. After simulation training, participants faced the critical, high-pressure, and often abusive "real world" in clinical sites, which may explain the drop in SE scoresr.

Identifying new methods to deliver cancer genetic counseling (GC) are needed to meet the growing interest in BRCA1/2 testing. The goal of this pilot feasibility study was designed to test the initial acceptability of group GC on selected patient outcomes (satisfaction, distress, perceived control) in a breast/ovarian cancer genetics clinic setting. Sixty-five participants at increased risk for hereditary breast/ovarian cancer (HBOC) agreed to participate in self-selected individual or group GC appointments. Forty-nine participants completed all study questionnaires and were included in the analyses. There were significant improvements for participants in both the individual and group GC formats with regard to perceived personal control, general psychological distress and cancer-specific psychological distress scores. Participants in both the individual and group formats reported high satisfaction scores on the Genetic Counseling Satisfaction Scale. Study results suggest that group GC may be feasible and acceptable to high-risk women.

Background The relationship between sleep quality and medical comorbidities of psoriasis and psoriatic arthritis is poorly understood. Objective To evaluate the association of sleep disturbance and medical comorbidities in patients with psoriasis and psoriatic arthritis compared with healthy volunteers. Methods This cross-sectional study compared patients with psoriasis, patients with psoriatic arthritis, and control participants. The Pittsburgh Sleep Quality Inventory (PSQI) and the Global Fatigue Scale were used to measure sleep disturbance and fatigue. Results The psoriatic arthritis, psoriasis, and control groups had elevated mean PSQI scores indicating poor sleep quality; the psoriatic arthritis group had the statistically highest mean score. Psoriatic arthritis patients had higher mean body mass index and a higher prevalence of diabetes, restless leg syndrome, and insomnia. Conclusions Poor sleep quality and medical comorbidities were prevalent in patients with psoriasis and psoriatic arthritis but are highest in patients with psoriatic arthritis. The link between sleep disorder, psoriatic disease, and medical comorbidities deserves more study.

Two groups now constitute the fastest growing segment of the U.S. prison population: women and persons with mental illness. Few large-scale studies have explored associations among serious mental illness (SMI), gender, and recidivism, or compared factors such as illness severity and clinical history as these construct notably different situations for incarcerated women and men. We report on our recent study comparing prison recidivism rates, severity of mental illness, and clinical history for women and men released from Utah State Prison 1998-2002.While women generally have better recidivism outcomes than men, we find that SMI related factors have a greater negative effect on the trajectories of women in this sample as compared with the men. This suggests that programs and policies focused on the SMI-specific risks and needs of women could significantly reduce prison recidivism and increase community tenure for this group, with far-reaching effects for families and communities.

Serious mental illness (SMI) represents a major risk for repeated incarceration, yet recidivism studies often do not specifically focus on persons with SMI as compared to non-SMI offenders. The study reported here systematically identified Utah State prisoners released from 1998 to 2002 ( N = 9,245) who meet criteria for SMI and compared SMI and non-SMI offenders on length of time to prison return. Findings indicate that 23% of the sample met criteria for SMI ( n = 2,112). Moreover, survival analyses demonstrated a significant difference in return rates and community tenure for offenders with SMI compared to non-SMI offenders when controlling for demographics, condition of release, offense type, and condition of return (parole violation vs. new commitment). The median time for all SMI offenders to return to prison was 385 days versus 743 days for all non-SMI offenders, 358 days sooner ( p < .001). Implications of these findings are discussed.

Summary Background The Utah Psoriasis Initiative (UPI) is an expanding database that is being used to identify and characterize phenotypic variants of psoriasis and explore genotype–phenotype relationships. We recently reported distinct morphological variants of psoriasis that are characterized by thickness of lesions (induration) in the untreated state. Objectives To explore the clinical relevance of these morphological variants. Methods For these analyses, we used the phenotypic data from 282 additional subjects gathered at enrolment into the UPI and compared their phenotype with that of the original 500 patients reported previously. The analysis was further expanded via a longitudinal follow-up of 286 subjects from the original 500 case cohort. Results Firstly, the initial findings were confirmed. Expansion of the cohort used for the original observation by about 50% and reanalysis showed that there was no alteration in the proportions of patients expressing thin- and thick-plaque disease phenotypes. Secondly, analysis of the larger cohort showed that this morphological phenotype had clinical relevance: those patients with thin-plaque disease were more likely to report a complete therapeutic response to topical corticosteroids and phototherapy. In contrast, plaque thickness did not appear to be a factor in response to systemic agents. Conclusions Using a patient’s baseline plaque morphology to choose a primary treatment modality may result in earlier disease improvement and reduce the cost of therapy.

Objective We sought to determine what clinical features of psoriasis predict sleep interference. Methods Data were obtained from 420 respondents to the 2005 National Psoriasis Foundation telephone and e-mail surveys. Logistic regression was used to determine whether disease severity, body mass index, age of onset, psoriatic arthritis, income, ethnicity, sex, current therapy, and quality-of-life measures predicted reported sleep interference within the last month. Results Psoriatic arthritis was the most significant predictor of sleep disturbance (odds ratio=3.26). Itch, pain of lesions, and impact on emotional well-being were also significant predictors (odds ratio 1.26, 1.22, and 1.18, respectively). Body surface area covered with psoriasis, body mass index, and therapy were not significant predictors of sleep interference. Limitations All data were self-reported and not physician-assessed. Conclusions History of psoriatic arthritis, presence of itch and pain of psoriatic lesions, and impact of psoriasis on overall emotional well-being predict sleep interference.

Purpose/Objectives: To introduce the use of a statistical technique known as multilevel growth-curve analysis and illustrate how the method can be advantageous in comparison with traditional repeated measures for the study of trajectories of signs and symptoms in individual patients over time. Data Sources: Data were derived from use of the technique in a randomized clinical trial of a psychoeducational intervention to reduce severity of oral mucositis and oral pain. Data Synthesis: The development of new biologic models that seek to explain clustering of signs and symptoms or the appearance and resolution of signs and symptoms motivates the need to use more sophisticated statistical techniques to test such models. Conclusions: The application of multilevel growth model to an existing data set demonstrates that the model can be effective in the study of individual differences in trajectories of change in signs and symptoms. Implications for Nursing: This method for the study of changes in patients' signs and symptoms over time can be of particular interest to nursing, both from a clinical point of view and as a way to test theoretical models that have been proposed to capture patient experiences with signs and symptoms.

Objective To determine the best sociodemographic and behavioral predictors for gestational diabetes mellitus (GDM) and birth weight (BW) and whether stress, depression, or abuse influences GDM and BW after controlling for sociodemographic variables. Design Retrospective correlational. Setting Utah Pregnancy Risk Monitoring System and birth certificate data. Participants We analyzed data from the birth certificates of 4,682 women with live births between 2009 and 2011 in Utah. During that time, a total of 143,373 live births occurred in the state. Data were predominantly from non-Hispanic White, married, or partnered women with average age of 27.5 years and average body mass index (BMI) of 25.1. Methods Stress, cumulative depression, and abuse were operationalized based on previous analysis, and control and covariate data (e.g., age, BMI, race, ethnicity, education, marital status) were collected. Bivariate analysis was used to identify associations between variables, and a hierarchical stepwise logistical regression was conducted to identify best predictors of GDM and BW. Results We did not find that cumulative depression, stress, or abuse was a predictor of GDM, and only cumulative stress was a predictor of BW. More incidences of GDM were observed in women who were poor, older, less educated, non-White, obese, or experienced depression during pregnancy. Conclusions Unlike depression or abuse, stress is often overlooked by providers. This finding represents an unmet opportunity for nurses to screen for and assist women with stressors to positively affect birth weight.

Background: Maternal psychosocial factors contribute to adverse pregnancy outcome, but very few studies have assessed associations of duration and experiences of stress, depression, and intimate partner violence (IPV) with maternal and newborn outcomes. Objectives: It was hypothesized that duration and level of maternal stress, depression, and IPV would predict increased risk of adverse maternal/newborn outcomes. Methods: A secondary data analysis of a population-based data set collected by the Utah Department of Health Pregnancy Risk Assessment and Monitoring System and birth certificates for 4682 live births was conducted, reflecting a total population size of 143,373 live births in 2009–2011. Exposures of interest were experiences and duration of maternal stress, depression, and IPV before and during pregnancy. Outcomes were gestational age, birth weight, newborn admission to the neonatal intensive care unit (NICU), and postpartum depression (PPD) symptoms and diagnosis. Results: After controlling for maternal demographics, body mass index, and smoking, women with greater duration of depression before and during pregnancy showed an increase in admission of their newborn to NICU (adjusted odds ratios [aORs] = 1.66–2.48, p < .001), PPD symptoms (aORs = 3.94–9.13, p < .001), and diagnosis of PPD (aORs = 7.72–59.60, p < .001). More kinds of experiences of maternal stress were associated with higher odds of PPD symptoms (aORs = 1.34–5.51, p < .001), but not PPD diagnosis or NICU admissions. Discussion: Longer lasting maternal depression and stress are associated with poorer outcomes for mothers and newborns. Future prospective studies should evaluate the usefulness of preconception and continuous prenatal risk identification of maternal depression and stress. This would facilitate timely psychosocial interventions as an approach to improving maternal/newborn outcomes for these higher risk women.

PURPOSE Many labor nurses routinely include continuous urinary catheterization (CC) as part of their standard care for women who receive intrapartum epidural anesthesia, to prevent urinary retention, thought to delay fetal descent. Recent studies question use of CCs during labor, as they may predispose patients to urinary tract infections (UTIs), even though the catheters are in place for a relatively short period of time. The objective of this study was to determine the influence of CCs versus intermittent catheters (ICs) (only as needed) on the duration of second stage of labor and the incidence of postpartum UTIs. STUDY DESIGN AND METHODS Randomized controlled trial. English-speaking low-risk nulliparous women ≥37 weeks gestation with a single fetus in a vertex presentation who requested an epidural were eligible for participation. Prior to epidural placement, cervical status was documented, women were encouraged to void, and then women were randomized to receive either CC or IC as the method for urinary bladder management for the duration of the first stage of labor. Final sample size included 123 participants; 55 in the CC group and 68 in the IC group. RESULTS No differences were noted in length of second stage labor, and the overall incidence of UTIs in both groups was low. There was a significantly increased likelihood of cesarean birth in women who had CC (P < .01) when compared to women who had IC. The overall cesarean rate in the CC group was 27.3%, versus 10.3% in the IC group. CLINICAL IMPLICATIONS Intermittent catheterization only as needed appears to be best practice for bladder management for laboring women with an epidural. There was a significantly higher rate of cesarean birth among women in the CC group. The relationship between route of birth and use of continuous indwelling urinary catheters for women in labor with epidurals for pain relief needs more study.

Psoriatic plaque thickness is a clinical measure of psoriasis severity. We have observed that patients tend to revert to a baseline thickness of psoriatic plaques when in an untreated state, and hypothesized that other features of psoriasis could associate with this trait. Data prospectively collected on 500 participants in the Utah Psoriasis Initiative were used for the study. In response to a question assessing plaque thickness when disease was at its worst, 144 (28.8%) reported thick plaques, 123 (24.6%) reported thin plaques, and 233 (46.6%) reported intermediate thickness. For patients with “worst-ever” disease at enrollment (n=122), there was significant correlation of thickness between assessment by the patient and the physician (r=0.448, P-value 0.01). Thick plaques associated with male gender, increased body mass index, nail disease, psoriatic arthritis, larger plaques, more body sites, and greater total body surface area affected. Thin plaques associated with eczema, guttate psoriasis, and skin cancer. We suggest that this is preliminary evidence that plaque thickness is an easily measured trait that associates with other clinical features of psoriasis, and that stratification on this phenotype may be useful in further defining the genetic basis of this disease.

OBJECTIVES/SPECIFIC AIMS: Exposure to theatrical performances holds promise for addressing bioethical issues, but there has been little empirical examination of the impact of dramatic presentation on audiences’ attitudes. This study assessed the short-term impact of the play, Informed Consent, on perceptions of trust, willingness to donate biospecimens, attitudes toward harm and privacy among the general public and in faculty, medical and undergraduate students within an academic medical center in the intermountain west. METHODS/STUDY POPULATION: Surveys were administered before and after a staged reading of the play by professional actors. Pre and post survey responses were linked for each participant. Survey items included the short form Trust in Medical Researchers, and single item questions about group identity, of genetic testing in children, and willingness to donate biospecimens. In total, 3 additional questions about harm, consent, and ethical investigator behavior as represented in the play were asked in the post survey. In addition, respondents were given the option to answer open-ended questions through email. RESULTS/ANTICIPATED RESULTS: Out of the 481 who attended the play, 421 completed both the pre and post surveys, and 166 participants completed open-ended questions online ~1 week after the play. Across all participants, there were significant declines for Trust in Medical Researchers and for the survey item “is it ethical for genetic testing in children for adult onset conditions,” (ppp=0.777). When differences were analyzed by race of the participant, non-White participants (n=68) compared with White participants (n=344) were less willing to donate biospecimens in general (pp=0.049) after viewing the play while the white participants’ willingness to donate was unchanged. Qualitative data provided extensive contextual data supporting these perspectives. DISCUSSION/SIGNIFICANCE OF IMPACT: This is one of the first studies to empirically examine the impact of a theatrical performance on both attitudes and behavioral intentions toward research and clinical research participation. Some attitudes changed following the play performance, but there were no significant differences on intention to donate biospecimens for research overall. Future research can further address the value and impact of theatrical performances and other creative arts as tools to engage the public and investigators in dialogue about the ethical issues and complexities in clinical research and further evaluation of the impact of performances on attitudes about research and ethics. Creative arts may be used to motivate investigators and study participants to confront fundamental questions about research participation and trust.

Evidence supports the premise that maternal psychological distress adversely affects pregnancy outcomes and that inflammatory markers and placentally-produced corticotrophin-releasing hormone (pCRH) are likely mediating factors. The primary aim of the study was to explore the associations between maternal psychological distress, use of selective serotonin re-uptake inhibitors, pCRH, and maternal plasma inflammatory markers during pregnancy. Measures of maternal plasma pCRH, Interleukins-1, 6, & 10, C-Reactive Protein, Macrophage Migration Inhibitory Factor, and Tumor Necrosis Factor-α were completed in 100 pregnant women. Measures of depression, anxiety, and perceived stress were completed, as well as collection of demographic/behavioral data, e.g. use of selective serotonin re-uptake inhibitors (SSRIs). Significant correlations were found at 14–20 weeks gestation between IL-6 & 10, and depression, anxiety, and perceived stress. Also at 14 – 20 weeks gestation, IL10 levels were significantly lower in women with 4th quartile pCRH levels and IL1β, IL6, and IL10 were significantly lower among women who took an SSRI during pregnancy. After controlling for maternal age, BMI, pCRH level, and SSRI use, psychological distress remained to explain variation in maternal inflammatory markers. These results might suggest that future research should focus on whether depression and anxiety are effectively being treated during pregnancy, and how such a scenario might contribute to an immune system pathway to poor pregnancy outcome.

IMPORTANCE: Research clearly indicates that current approaches to newborn blood spot screening (NBS) education are ineffective. Incorporating NBS education into prenatal care is broadly supported by lay and professional opinion. OBJECTIVE: To determine the efficacy and effect of prenatal education about newborn screening and use of residual dried blood spots (DBS) in research on parental knowledge, attitudes, and behaviors. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of prenatal educational interventions, with outcomes measured by survey at 2 to 4 weeks postpartum. Participants were recruited from obstetric clinics in Salt Lake City, Utah; San Francisco, California; and the Bronx, New York. Eligible women were English- or Spanish-speaking adults and did not have a high-risk pregnancy. A total of 901 women were enrolled. Participants who completed the follow-up survey included 212 women in the usual care group (70% retention), 231 in the NBS group (77% retention), and 221 women in the NBS + DBS group (75% retention). Those who completed the survey were similar across the 3 groups with respect to age, ethnicity, race, education, marital status, income, obstetric history, and language. INTERVENTIONS: Participants were randomized into 1 of 3 groups: usual care (n = 305), those viewing an NBS movie and brochure (n = 300), and those viewing both the NBS and DBS movies and brochures (n = 296). MAIN OUTCOMES AND MEASURES: Two to four weeks postpartum, women completed a 91-item survey by telephone, addressing knowledge, attitudes, and behavior with respect to opting out of NBS or DBS for their child. RESULTS: A total of 901 women (mean age, 31 years) were randomized and 664 completed the follow-up survey. The total correct responses on the knowledge instrument in regard to NBS were 69% in the usual care group, 79% in the NBS group, and 75% in the NBS + DBS group, a significant between-group difference (P < .05). Although all groups showed strong support for NBS, the percentage of women who were “very supportive” was highest in the NBS group (94%), followed by the NBS + DBS group (86%) and was lowest in the usual care group (73%) (P < .001). The interventions were not associated with decisions to decline newborn screening or withdraw residual DBS. Nine women stated that they had declined NBS (all the usual care group; P < .001). With respect to DBS, 5 participants indicated that they contacted the health department to have their child’s sample withdrawn after testing: 3 in the NBS + DBS group and 2 in the usual care group (P = .25). CONCLUSIONS AND RELEVANCE: Educational interventions can be implemented in the prenatal clinic, using multimedia tools and electronic platforms. Prenatal education is effective in increasing postnatal knowledge and support for these programs. These results are relevant to other contexts in which residual clinical specimens and data are used for research purposes. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02676245

The US emergency departments and poison control centers use telephone communication to exchange information about poison exposed patients. Electronically exchanged patient information could better support care for poisoned patients by improving information availability for decision making and by decreasing unnecessary emergency department telephone interruptions. As federal initiatives push to increase clinical health information exchange (HIE), it is essential to assess the readiness of US poison control centers. We conducted a nationwide Delphi study to determine consensus on legal, operational, and clinical considerations that are important for electronic information exchange between emergency departments and poison control centers.A national panel of US experts (n = 71) in emergency medicine and poison control participated in a Delphi study, September-December 2010. Panelists rated statements describing concepts related to implementation, adoption, or potential outcomes of electronic information exchange between emergency departments and poison control centers. The statements reflected panelist responses to initial open-ended questions and literature-based concepts.A total of 71 panelists agreed to participate. The response rate for each round ranged from 0.73 to 0.77. Most (114/121) statements reached consensus. Seven statements failed to reach consensus. Panelists indicated that user involvement in the design of systems and tools is important. Workflow integration, safety, evidence of benefit, and outcomes are high-importance issues.Future research and development related to electronic information exchange should address high-importance issues: safety, patient outcomes, workflow integration, and evidence of benefit. It should also address key barriers: initial and ongoing costs associated with electronic information exchange, the absence of software and tools to facilitate exchange, and the need for training. Users should be involved in the design of an electronic information exchange process, and the process should support, not replace, verbal communication.

BACKGROUND AND OBJECTIVES: Many state newborn screening (NBS) programs retain residual NBS bloodspots after the completion of screening. Potential uses for residual specimens include laboratory quality assurance, biomedical research, and, rarely, forensic applications. Our objective was to evaluate public opinion about the policies and practices relevant to the retention and use of residual bloodspots for biomedical research. METHODS: A total of 3855 respondents were recruited using 3 methods: focus groups (n = 157), paper or telephone surveys (n = 1418), and a Knowledge Networks panel (n = 2280). Some participants (n = 1769) viewed a 22-minute movie about the retention and use of residual specimens while other participants were provided only written information about this practice. All participants were surveyed using a 38-item questionnaire. RESULTS: A diverse set of participants was recruited. Respondents were very supportive of NBS in general and accepting of the use of residual bloodspots for important research activities. Respondents were evenly divided on the acceptability of NBS without parental permission, but the majority of respondents supported the use of an “opt-in” process for parental permission for residual bloodspot retention and use. Viewing the educational movie was associated with greater support for bloodspot retention and use. CONCLUSIONS: Our results show that the general public surveyed here was supportive of NBS and residual sample retention and research use. However, there was a clear preference for an informed permission process for parents regarding these activities. Education about NBS was associated with a higher level of support and may be important to maintain public trust in these important programs.

Objectives. We assessed attitudes and opinions of members of newborn blood screening (NBS) advisory committees regarding the storage and secondary research use of residual specimens from NBS. Methods. We conducted focus groups in 2008 and 2009 with NBS advisory committees (4 focus groups; n = 39 participants) in the Mountain States region (i.e., AZ, CO, MT, NM, NV, TX, UT, and WY). Results. Participants identified several challenges to implementing policies for storage of and research on residual newborn blood specimens. Themes that emerged from the data were public health relevancy; improvement of parental knowledge; impact of enhanced parental involvement; concerns over ownership, privacy, and confidentiality; identification of secondary research uses; and role of advisory committees. Conclusions. Participants indicated that secondary uses of residual specimens entailed opportunities for improvements in NBS programs but also carried significant risks for their programs. Addressing concerns from stakeholders will be necessary for state-level adoption of national recommendations.

Objective This study aimed to compare 3 treatment modalities during sleep at an altitude of 5300 m to identify strategies for reducing the incidence of periodic breathing at high altitude. Methods Fifteen trekkers, with identical ascent profiles and no signs or symptoms of altitude illness, served as subjects. All study participants arrived at 5300 m after a gradual ascent from 1300 m. On their second night at 5300 m, subjects were randomly assigned (with a computer - based random assignment procedure) to 1 of 4 different treatment groups: control ( n = 4); 1 L/min O 2 via a demand system during sleep ( n = 3); 1 L/min O 2 /CO 2 mix (1.5% CO 2 ) via a demand system during sleep ( n = 4); or 125 mg acetazolamide 30 minutes before bedtime ( n = 4). Heart rate, respiration rate, blood oxygen saturation, tidal volume, minute volume, and apnea hypopnea index were measured. Results Upon comparing the 4 groups, there were no statistically significant differences between the variables. One-way analysis of variance indicated a trend toward statistical significance for SaO 2 between groups (F = 2.9, P = .08), and Tukey Honestly Significant Difference (HSD) post hoc tests indicated a trend in the SaO 2 difference between the 1 L/min oxygen and control groups ( P = .07). While 1-way analysis of variance suggested no difference for respiratory rate between groups (F = 2.5, P = .1), Tukey HSD indicated a trend in statistical difference of the respiratory rate between 1 L/min O 2 and 1 L/min O 2 /CO 2 mixture ( P = .08). Conclusions These statistical trends found between control and treatment groups indicate that further study is warranted.

To study whether obesity increases the risk of psoriatic arthritis (PsA), given that obesity is a risk factor for psoriasis and is associated with more severe disease.Case series. We used Cox regression analysis to study the relationship between obesity and PsA while controlling for age at psoriasis onset, current body mass index (BMI), sex, family history of psoriasis, worst-ever body surface area (BSA) involvement, Koebner phenomenon, and nail involvement.Dermatology clinics at the University of Utah School of Medicine. Patients Volunteer sample of patients with dermatologist-diagnosed psoriasis enrolled in the Utah Psoriasis Initiative from November 2002 to October 2008 (943 subjects; 50.2% women, 49.8% men).Physician diagnosis of PsA from self-report questionnaire.In our subjects, we found that BMI at age 18 years was predictive of PsA (odds ratio [OR], 1.06) (P.01) over and above control variables. Other variables that were predictors of PsA included younger age at psoriasis onset (odds ratio [OR], 0.98) (P.01), female sex (OR, 1.45) (P = .01), higher worst-ever BSA involvement with psoriasis (OR, 1.01) (P = .04), Koebner phenomenon (OR, 1.59) (P.01), and nail involvement (OR, 1.76) (P.01). Current BMI and family history of psoriasis were not significant predictors of PsA.This study suggests that obesity at age 18 years increases the risk of developing PsA. Adiposity is associated with higher levels of inflammatory cytokines known to be associated with psoriasis. This inflammatory milieu could increase the risk of PsA in predisposed subjects. Prevention and early treatment of obesity may decrease the risk of PsA.

This presentation is to demonstrate how a ubiquitous database program (Microsoft Access) was utilized to collect data when individuals' symptoms, and the self-care strategies they implemented, changed on a week to week basis.

The goal of this study is to characterize sleep quality and quantity prior to and in the first three nights after initial chemotherapy for breast cancer.This study makes use of secondary analysis of data from two separate randomized clinical trials (RCT) of behavioral interventions to improve fatigue and sleep. Patients came from two comprehensive cancer centers, three clinical cancer centers, and 10 community clinics in five states. Participants were women with stage I-IIIA breast cancer treated with anthracycline and/or cyclophosphamide-based regimens.Baseline data from each RCT were used in the analysis. Sixty-five percent of women self-reported poor sleep in the month preceding chemotherapy using the Pittsburgh Sleep Quality Index (PSQI) score5. Three nights of actigraphy data indicated a wide range of sleep experience with an average of 10 awakenings and time (minutes) awake after sleep onset (WASO-M) averaging 61 min per night. The first night's sleep was the worst. There was no statistically significant relationship between self-reported poor sleep and sleep measures obtained by actigraphy. Women with poor sleep at baseline (global PSQI5) had significantly lower (p0.001) physical (PCS) and mental (MCS) health status. However, neither the PCS nor MCS was associated with any of the average actigraphy sleep parameters or night 1 parameters in the aggregated sample. Increasing age was also associated with poorer sleep.A high percent of women with breast cancer begin chemotherapy with disturbed sleep and the initial nights after chemotherapy are characterized by sleep fragmentation that disrupts sleep maintenance. Interventions should focus on strategies to decrease the number and duration of night awakenings. Further research is needed to identify predictors of poor sleep during this time.

Objectives Demonstrate knowledge of domains of care discussed during nurse home hospice visits. Identify the proportion and change over time dedicated to domains of care during nurse home hospice visits. Original Research Background: Physical, emotional, and spiritual needs of cancer patients and their caregivers vary during the course of hospice care. However, little is known about communication between hospice nurses, patients, and caregivers regarding these needs during home hospice visits. Research Objectives

85 Background: Family caregivers face the task of providing end of life care (EOL) in the home setting and need effective caregiving support. Although not previously tested in EOL care, automated symptom monitoring has shown promise for cancer patients on active treatment. This study tests an automated monitoring and coaching system for family caregivers during home hospice. Methods: Family Caregivers (FC) of hospice cancer patients (PT) (N=243 dyads) were monitored daily using an automated telephone symptom monitoring system, and randomly assigned to receive the symptom care intervention (SC) (N=119) or usual care (UC) (N=124). All FCs called the monitoring system daily, reporting by proxy, past 24 hour presence, severity and FC distress on 11 common PT symptoms (0–10 scale). In addition, FCs reported their own fatigue, sleep, mood and anxiety severity (0-10 scale). The SC intervention FCs received automated tailored symptom care coaching based on reported patterns; in addition symptoms moderate or greater generated alerts to their hospice nurse. Results: Most FCs and PTs were White (95; 94%), 66% of FCs and 48% of PTs were female with the Mean age for FCs 60 and 73 for PTs. Most frequent PT symptoms were fatigue (70%), pain (64%), poor appetite (54%), anxiety (39%), and change in thinking (38%). PT symptom severity levels were highly related to FC distress. Preliminary analyses indicates that FC vitality (FC combined symptoms) improved more in the SC group (p=.003, mixed effects model). Furthermore PT symptom severity, categorized as Mild (=7), provided strong preliminary evidence of SC intervention benefit in each of the first four weeks in hospice care and overall (p=.003). Rapid onset of the SC benefit was suggested by Kaplan-Meier analysis of time to first all-zero symptom profile (p=.06 log-rank). The benefit of the SC intervention continued throughout the hospice stay until the last several days of life when there was no difference with UC. Conclusions: This is the first reported evaluation of automated symptom monitoring in home EOL care and provides strong preliminary evidence of benefit for cancer family caregivers and patients. Clinical trial information: NCT02112461.

2 Background: An automated remote monitoring system of patient reported symptoms was tested in two separate trials to determine if it improved unrelieved symptoms after outpatient chemotherapy. Methods: In Study 1,250 patients and Study 2,335 patients beginning a chemotherapy course were randomized to Telephone Care (TC) (n 129/174) or usual care (UC) (n 121/162). All called daily reporting presence, severity, and distress (0-10 scale) for 11 common symptoms. Those in the Study 1 TC group had reports of moderate to severe symptoms emailed to their oncologist and oncology nurse. Those in Study 2 TC group had similar moderate to severe symptom reports sent to a study Nurse Practitioner (NP) who responded by telephone utilizing evidence based guidelines to intensify symptom care. These patients also received automated tailored self-care messages based on their specific symptoms. Results: The majority of participants in both studies were white (91%; 84%) and female (76%; 77%). The mean age was 56 years, with breast cancer most common (40%; 45%). Mean study days were 45 (Study 1) and 73 (Study 2) with 66% and 87% call completion days respectively. Fatigue, pain, poor sleep, nausea and depressed mood were reported as moderate to severe by over 50% of patients in both studies. In Study 1 no difference was found in symptom severity between TC and UC. Oncology providers found the TC symptom alerts useful but rarely initiated symptom care intensification. In Study 2 the TC group mean symptom score was significantly lower than UC, p < .001. Poisson regression showed TC had fewer Severe symptom days than UC (est. means and SE) 3.16 (0.44) vs. 10.24 (1.84), p < .001; and fewer Moderate days 8.91 (1.04) vs. 19.06 (2.22), p < .001. TC had somewhat higher Mild days 19.85 (2.81) vs. 13.75 (1.85), p = .06; and more no symptom days 66.06 (3.82) vs 52.02 (4.15), p = .01. Conclusions: Remote monitoring of patient reported symptoms after chemotherapy is effective in identifying unrelieved symptoms. It can be used to track quality improvement as well as augment symptom care. Follow up to intensify symptom treatment utilizing guidelines is necessary to achieve significant reductions in symptom severity, distress and days of moderate or severe symptoms.

9137 Background: We tested an automated computer based remote monitoring system paired with nurse practitioner (NP) follow up using a case management system to address unrelieved symptoms. Methods: Prospectively 336 patients beginning a course of chemotherapy were randomized to the Telephone Care NP (TC) intervention (n 174) or usual care (UC) (n 162). All called daily reporting presence, severity, and distress (0-10 scale) for 11 common symptoms. Those in the TC intervention also received automated tailored symptom self-care messages and, based on automated alerts for unrelieved symptoms at moderate or higher levels, NP calls to further treat symptoms utilizing national guidelines. Results: There were no differences between groups on any demographics: 84% White, 56 years old, female (77%), breast (45%) or lung (17%) cancer. Average study days were 73 with 87% call completion. Prevalence of participants reporting moderate to severe symptoms were fatigue (86%), pain (80%), sleep (78%), nausea (60%), depressed mood (52%), anxious (49%), trouble thinking (48%), numbness (43%), sore mouth (38%), diarrhea (38%), and appearance concerns (35%). Mixed modeling with intention to treat was used to compare overall symptom scores by treatment condition (TC/UC) while accounting for individuals. Results indicate the TC group mean symptom score was significantly lower than UC (mean difference = .30, p < .001). Also, each symptom was significantly lower for the TC group except for diarrhea. Poisson regression showed TC had lower Severe days than UC (est. means and SE) 3.16 (0.44) vs 10.24 (1.84), p < .001; and lower Moderate days 8.91 (1.04) vs 19.06 (2.22), p < .001. TC had somewhat higher Mild days than UC 19.85 (2.81) vs 13.75 (1.85), p = .06; and more No symptom days 66.06 (3.82) vs 52.02 (4.15), p = .01. Mixed modeling was used to explore TC intervention impact following NP calls for alerts. TC reduced symptom scores compared to UC over a 4 day period (mean difference = 1.28, p< .001). Conclusions: Remote telephone monitoring of symptoms after chemotherapy with nurse practitioner follow up on moderate and severe symptoms results in decreased symptom severity, distress, fewer severe and moderate days and more no symptom days.

Genetic and environmental factors influence the development of psoriasis (Ps) and psoriatic arthritis (PsA). Recently, we reported that three IL13 polymorphisms, rs1800925, rs20541, and rs848, on chromosome 5q31 conferred the risk for Ps. IL13 encodes IL-13, a Th2 cytokine, and rs1800925 and rs20541 confer risk of asthma. Further, smoking may increase the risk of developing Ps. We examined the association between IL13 polymorphisms, smoking, and PsA in two Ps sample sets genotyped for rs1800925, rs20541, and rs848. We found that the minor alleles (rs1800925*T, rs20541*A, and rs848*A) were significantly associated with protection from PsA versus controls, and that no association with Ps is seen when the PsA cases are excluded. This effect was strongest with rs1800925*T (odds ratio (OR) 0.40, P(allelic) 0.000067). The prevalence of PsA in cases with the rs1800925*CT or TT genotype is about half that of those with the CC genotype (15.5 vs 32.1%, P=0.0002). However, smoking appears to abrogate this effect (CT/TT/non-smoker, prevalence of PsA 13%, OR 0.20, P=0.0001; CT/TT/smoker, prevalence 38%, OR 0.88, P=0.74, CC/non-smoker, prevalence 42% (reference), CC/smoker prevalence 47%, OR 1.21, P=0.47). This study suggests that IL13 polymorphisms associate most strongly with PsA and that smoking may modulate this effect.