OBJECTIVE:To determine if natural human papillomavirus (HPV) infection would induce an anamnestic response to quadrivalent (qHPV) vaccine in women with Systemic Lupus Erythematosus (SLE).METHODS:Thirty four women (19-50 years) with mild to moderate and minimally active or inactive SLE received standard qHPV vaccine. Neutralizing antibody titers to HPV 6, 11, 16 and18 were evaluated pre- and post- vaccine using HPV competitive Luminex Immunoassay. For each HPV type, logistic regressions were performed to explore the relationship between a positive titer at baseline with their final geometric mean titer and with the rise in titer. Fisher's Exact Test was used to assess the association of at least one positive HPV antibody test at baseline and history of abnormal pap.RESULTS:History of abnormal pap smear/cervical neoplasia occurred in 52.9%. Baseline anti HPV antibody titers: 21% = negative for all 4 HPV types, 79% = positive for ≥1 of the HPV types. Statistical analysis showed: those with a history of abnormal pap smear/cervical neoplasia were likely to have a positive anti-HPV antibody result pre-vaccine to ≥ 1 of the 4 types, p = 0.035 Fisher's Exact Test. In general, HPV exposed women showed higher post vaccine GMTs than HPV unexposed women with higher point estimates. However, when examining the rise in titers using logistic regression, there was no evidence of an anamnestic response.CONCLUSION:Prior HPV infection and cervical neoplasia in SLE are linked with no anamnestic response to HPV vaccine. This supports not checking HPV-antibodies pre-vaccine. Women with SLE should be vaccinated for HPV.

OBJECTIVE:This study evaluated the safety and immunogenicity of qHPV vaccine in SLE. METHODS:Subjects: 34 women ages 19-50years (yrs.) with mild to moderate SLE & minimally active or inactive SLE received qHPV vaccine at the standard dosing schedule. EXCLUSION CRITERIA:active SLE disease (SELENA-SLEDAI>2), history of severe SLE disease, deep venous thrombosis, on >400mg/day of hydroxychloroquine, on >15mg/day of prednisone, or active infections. Patients were monitored for adverse events (AE), SLE flare, generation of thrombogenic antibodies and thrombosis. Antibody (Ab) levels to HPV 6, 11, 16 & 18 were measured by HPV competitive Luminex Immunoassay and Geometric Mean Titers (GMTs) were calculated for each HPV type. Seroconversion was assessed for those seronegative at baseline. RESULTS:The women in the study: African-American (79%), mean age=38.1years, mean age at diagnosis of SLE=28.6years, 35.3% had a history of smoking, 91% had 4 or more sexual partners, 50% had a history of sexually transmitted diseases, and 27.3% used condoms on a regular basis. Vaccine site reactions (VSRs) occurred in 62%, all mild. Ninety-seven percent experienced at least 1 non vaccine adverse event (nvAE) with a total of 493 nvAEs in 33 patients, of which 90% were mild and none were related to vaccine or SLE. There were 9 serious AEs, none were related to vaccine or SLE, all resolved. No patient experienced an SLE flare, thrombosis, or generation of thrombogenic antibodies. Seroconversion rate was 100% with mean GMTs comparable to Gardasil® package insert data. CONCLUSION:In this SLE vaccine study, qHPV vaccine was generally safe, well tolerated, and highly immunogenic. This clinical trial is registered on Clinical Trials.gov under number, NCT01741012 and was conducted under the FDA IND BB14113.

We are grateful for the thoughtful comments on our recent article, “Underreporting of Workplace Violence: Comparison of Self-Report and Actual Documentation of Hospital Incidents” (Arnetz, Hamblin, Ager, et al., 2015). The writer raises issues that are well worthy of discussion. However, on a number of points, there has been some misunderstanding that we hope this response will clarify.

PURPOSE Overtreatment of screen-detected localized prostate cancer (LPC) is an important public health concern, since the survival benefit of aggressive treatment (surgery or radiation) has not been well established. We investigated the survival expectations of patients who had LPC with and without their chosen treatment.METHODS A population-based sample of 260 men (132 black, 128 white) 75 years old or younger with newly diagnosed LPC completed a self-administered survey. How long the patients expected to live with their chosen treatment, how long they would expect to live with no treatment, and factors associated with the difference in perceived life expectancy were assessed using multivariable analysis.RESULTS Without any treatment, 33% of patients expected that they would live less than 5 years, 41% 5 to 10 years, 21% 10 to 20 years, and 5% more than 20 years. With their chosen treatment, 3% of patients expected to live less than 5 years, 9% 5 to 10 years, 33% 10 to 20 years, and 55% more than 20 years. Treatment chosen, age, general health perception, and perceived cancer seriousness predicted the differences in perceived life expectancy, while race and actual tumor risk did not. After adjustment for other covariates, men who choose surgery or radiation expected greater gain in survival than men who chose watchful waiting or active surveillance.CONCLUSIONS Most patients with LPC underestimated their life expectancy without treatment and overestimated the gain in life expectancy with surgery or radiation. These unrealistic expectations may compromise patients' ability to make informed treatment decisions and may contribute to overtreatment of LPC. Primary care physicians, when included in the decision process, should focus on helping patients develop realistic expectations and choices that support their treatment goals.

Worker-to-worker (Type III) violence is prevalent in health care settings and has potential adverse consequences for employees and organizations. Little research has examined perpetrator characteristics of this type of violence. The current study is a descriptive examination of the common demographic and work-related characteristics of perpetrators of Type III workplace violence among hospital workers. Analysis was based on documented incidents of Type III violence reported within a large hospital system from 2010 to 2012. Nurses were involved as either the perpetrator or target in the five most common perpetrator-target dyads. Incidence rate ratios revealed that patient care associates and nurses were significantly more likely to be perpetrators than other job titles. By examining characteristics of perpetrators and common worker dyads involved in Type III workplace violence, hospital stakeholders and unit supervisors have a starting point to develop strategies for reducing conflict between workers.

AIMS AND OBJECTIVES:To identify common catalysts of worker-to-worker violence and incivility in hospital settings.BACKGROUND:Worker-to-worker violence and incivility are prevalent forms of mistreatment in healthcare workplaces. These are forms of counterproductive work behaviour that can lead to negative outcomes for employees, patients and the organisation overall. Identifying the factors that lead to co-worker mistreatment is a critical first step in the development of interventions targeting these behaviours.DESIGN:Retrospective descriptive study.METHODS:Qualitative content analysis was conducted on the total sample (n = 141) of employee incident reports of worker-to-worker violence and incivility that were documented in 2011 at a large American hospital system.RESULTS:More than 50% of the incidents involved nurses, and the majority of incidents did not involve physical violence. Two primary themes emerged from the analysis: Work Behaviour and Work Organisation. Incidents in the Work Behaviour category were often sparked by unprofessional behaviour, disagreement over responsibilities for work tasks or methods of patient care, and dissatisfaction with a co-worker's performance. Incidents in the Work Organisation category involved conflicts or aggression arising from failure to following protocol, patient assignments, limited resources and high workload.CONCLUSION:Incidents of worker-to-worker violence and incivility stemmed from dissatisfaction with employee behaviour or from organisational practices or work constraints. These incident descriptions reflect worker dissatisfaction and frustration, resulting from poor communication and collaboration between employees, all of which threaten work productivity.RELEVANCE TO CLINICAL PRACTICE:Violence and incivility between hospital employees can contribute to turnover of top performers, hinder effective teamwork and jeopardise the quality of patient care. Identification of common catalysts for worker-to-worker violence and incivility informs the development of mistreatment prevention programmes that can be used to educate hospital staff.

Objective To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications. Design Randomized, prospective clinical trial. Setting Multicenter university-based clinical practices. Patient(s) A total of 900 couples with unexplained infertility. Intervention(s) Collection of baseline demographics, blood samples, and ultrasonographic assessments. Main Outcome Measure(s) Demographic, laboratory, imaging, and survey characteristics. Result(s) Demographic characteristics of women receiving clomiphene citrate (CC), letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7 ± 25.7 months, with 59% primary infertility. More than one-third of the women were current or past smokers. The mean body mass index (BMI) was 27 and mean antimüllerian hormone level was 2.6; only 11 women (1.3%) had antral follicle counts of <5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners. Conclusion(s) The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, antimüllerian hormone levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment groups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and CC treatment. Clinical Trial Registration Number NCT 01044862.

Purpose Racial differences in prostate cancer treatment patterns have motivated concerns about over- and undertreatment. We surveyed black and white patients with localized prostate cancer (LPC) regarding their treatment decision-making processes to gain a better perspective on factors associated with LPC treatment choice. Methods We conducted a population-based, cross-sectional survey of 260 men (132 black, 128 white) aged ≤75 years, with newly diagnosed LPC. Our primary outcome was treatment choice (either surgery, radiation, or watchful waiting/active surveillance (WW/AS)), and our primary predictors were race and tumor risk level. Results Overall, treatment choice did not differ by race. As cancer risk increased, both black and white patients were more likely to undergo surgery and less likely to receive radiation. However, the pattern of WW/AS was different between white and black men. White men were less likely to select WW/AS as cancer risk increased, while risk level was unrelated to black men undergoing WW/AS. Urologist’s recommendation had the greatest impact on men’s treatment choice, followed by tumor risk level, age, and personal preferences. Conclusions Although there were no overall racial differences in treatment choice, when stratified by tumor risk level, the pattern of WW/AS was different between white and black patients, suggesting that over- and undertreatment is a larger concern for black than white men. A risk-stratified approach to understand racial disparities in LPC treatment and better strategies to aid black men in their treatment decision-making are needed to reduce racial disparities in prostate cancer outcomes.

BACKGROUND:The standard therapy for women with unexplained infertility is gonadotropin or clomiphene citrate. Ovarian stimulation with letrozole has been proposed to reduce multiple gestations while maintaining live birth rates.METHODS:We enrolled couples with unexplained infertility in a multicenter, randomized trial. Ovulatory women 18 to 40 years of age with at least one patent fallopian tube were randomly assigned to ovarian stimulation (up to four cycles) with gonadotropin (301 women), clomiphene (300), or letrozole (299). The primary outcome was the rate of multiple gestations among women with clinical pregnancies.RESULTS:After treatment with gonadotropin, clomiphene, or letrozole, clinical pregnancies occurred in 35.5%, 28.3%, and 22.4% of cycles, and live birth in 32.2%, 23.3%, and 18.7%, respectively; pregnancy rates with letrozole were significantly lower than the rates with standard therapy (gonadotropin or clomiphene) (P=0.003) or gonadotropin alone (P<0.001) but not with clomiphene alone (P=0.10). Among ongoing pregnancies with fetal heart activity, the multiple gestation rate with letrozole (9 of 67 pregnancies, 13%) did not differ significantly from the rate with gonadotropin or clomiphene (42 of 192, 22%; P=0.15) or clomiphene alone (8 of 85, 9%; P=0.44) but was lower than the rate with gonadotropin alone (34 of 107, 32%; P=0.006). All multiple gestations in the clomiphene and letrozole groups were twins, whereas gonadotropin treatment resulted in 24 twin and 10 triplet gestations. There were no significant differences among groups in the frequencies of congenital anomalies or major fetal and neonatal complications.CONCLUSIONS:In women with unexplained infertility, ovarian stimulation with letrozole resulted in a significantly lower frequency of multiple gestation but also a lower frequency of live birth, as compared with gonadotropin but not as compared with clomiphene. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT01044862.).

This study examined differences between self-report and actual documentation of workplace violence (WPV) incidents in a cohort of health care workers. The study was conducted in an American hospital system with a central electronic database for reporting WPV events. In 2013, employees ( n = 2010) were surveyed by mail about their experience of WPV in the previous year. Survey responses were compared with actual events entered into the electronic system. Of questionnaire respondents who self-reported a violent event in the past year, 88% had not documented an incident in the electronic system. However, more than 45% had reported violence informally, for example, to their supervisors. The researchers found that if employees were injured or lost time from work, they were more likely to formally report a violent event. Understanding the magnitude of underreporting and characteristics of health care workers who are less likely to report may assist hospitals in determining where to focus violence education and prevention efforts.

BACKGROUND: Documented incidents of violence provide the foundation for any workplace violence prevention program. However, no published research to date has examined stakeholders' preferences for workplace violence data reports in healthcare settings. If relevant data are not readily available a nd effectively summarized and presented, the likelihood is low that they will be utilized by stakeholders in targeted efforts to reduce violence. OBJECTIVE: To discover and describe hospital system stakeholders' perceptions of database-generated workplace violence data reports. PARTICIPANTS: Eight hospital system stakeholders representing Human Resources, Security, Occupational Health Services, Quality and Safety, and Labor in a large, metropolitan hospital system. METHODS: The hospital system utilizes a central database for reporting adverse workplace events, including incidents of violence. A focus group was conducted to identify stakeholders' preferences and specifications for standardized, computerized reports of workplace violence data to be generated by the central database. The discussion was audio-taped, transcribed verbatim, processed as text, and analyzed using stepwise content analysis. RESULTS: Five distinct themes emerged from participant responses: Concerns, Etiology, Customization, Use, and Outcomes. In general, stakeholders wanted data reports to provide ``the big picture,'' i.e., rates of occurrence; reasons for and details regarding incident occurrence; consequences for the individual employee and/or the workplace; and organizational efforts that were employed to deal with the incident. CONCLUSIONS: Exploring stakeholder views regarding workplace violence summary reports provided concrete information on the preferred content, format, and use of workplace violence data. Participants desired both epidemiological and incident-specific data in order to better understand and work to prevent the workplace violence occurring in their hospital system.

Aim. To explore catalysts to, and circumstances surrounding, patient-to-worker violent incidents recorded by employees in a hospital system database.Background. Violence by patients towards healthcare workers (Type II workplace violence) is a significant occupational hazard in hospitals worldwide. Studies to date have failed to investigate its root causes due to a lack of empirical research based on documented episodes of patient violence.Design. Qualitative content analysis.Methods. Content analysis was conducted on the total sample of 214 Type II incidents documented in 2011 by employees of an American hospital system with a centralized reporting system.Findings. The majority of incidents were reported by nurses (39.8%),security staff (15.9%) and nurse assistants (14.4%). Three distinct themes were identified from the analysis: Patient Behaviour, Patient Care and Situational Events. Specific causes of violence related to Patient Behaviour were cognitive impairment and demanding to leave. Catalysts related to patient care were the use of needles, patient pain/discomfort and physical transfers of patients. Situational factors included the use/presence of restraints; transitions in the care process; intervening to protect patients and/or staff; and redirecting patients.Conclusions. Identifying catalysts and situations involved in patient violence in hospitals informs administrators about potential targets for intervention. Hospital staff can be trained to recognize these specific risk factors for patient violence and can be educated in how to best mitigate or prevent the most common forms of violent behaviour. A social-ecological model can be adapted to the hospital setting as a framework for prevention of patient violence towards staff.

BACKGROUND:Persistently elevated blood pressure (BP) is a leading risk factor for cardiovascular disease development, making effective hypertension management an issue of considerable public health importance. Hypertension is particularly prominent among African Americans, who have higher disease prevalence and consistently lower BP control than Whites and Hispanics. Emergency departments (ED) have limited resources for chronic disease management, especially for under-served patients dependent upon the ED for primary care, and are not equipped to conduct follow-up. Kiosk-based patient education has been found to be effective in primary care settings, but little research has been done on the effectiveness of interactive patient education modules as ED enhanced discharge for an under-served urban minority population.METHODS/DESIGN:Achieving Blood Pressure Control Through Enhanced Discharge (AchieveBP) is a behavioral RCT patient education intervention for patients with a history of hypertension who have uncontrolled BP at ED discharge. The project will recruit up to 200 eligible participants at the ED, primarily African-American, who will be asked to return to a nearby clinical research center for seven, thirty and ninety day visits, with a 180 day follow-up. Consenting participants will be randomized to either an attention-control or kiosk-based interactive patient education intervention. To control for potential medication effects, all participants will be prescribed similar, evidenced-based anti-hypertensive regimens and have their prescription filled onsite at the ED and during visits to the clinic. The primary target endpoint will be success in achieving BP control assessed at 180 days follow-up post-ED discharge. The secondary aim will be to assess the relationship between patient activation and self-care management.DISCUSSION:The AchieveBP trial will determine whether using interactive patient education delivered through health information technology as ED enhanced discharge with subsequent education sessions at a clinic is an effective strategy for achieving short-term patient management of BP. The project is innovative in that it uses the ED as an initial point of service for kiosk-based health education designed to increase BP self-management. It is anticipated findings from this translational research could also be used as a resource for patient education and follow-up with hypertensive patients in primary care settings.TRIAL REGISTRATION:ClinicalTrials.gov.REGISTRATION NUMBER:NCT02069015. Registered February 19, 2014.

Background Pregnancy substance use is linked to low birth weight. However, less is known about relative contributions of various substances and whether effects are due to decreased gestational duration, restriction of fetal growth, or both. The study goal was to use causal modeling to evaluate the individual impact of alcohol, tobacco, cocaine, and marijuana on gestational duration and fetal growth. Methods Participants were 3164 urban black women recruited at entry to prenatal care and followed to delivery, with all gestational dating ultrasound supported. Pregnancy substance use was assessed via self-report (alcohol, tobacco, cocaine, and marijuana). Results Alcohol, cigarette, and cocaine use were all individually and negatively related to gestational age at delivery. However, only alcohol, cigarette, and marijuana use predicted fetal growth, with effects for alcohol and cigarette greater and more discrepant for older women. Overall, heavy cigarette smoking had the greatest individual impact on birth weight (up to 431 g). Heavy levels of use of all 4 substances by older women decreased birth weight by 26% (806 g). Conclusions For perhaps the first time, reduced birth weight is apportioned both by type of substance and mechanism of effect. The use of alcohol and/or cigarettes was clearly more harmful to fetal growth than cocaine use. Findings demonstrate the need for continued emphasis on intervention efforts to address legal and illicit pregnancy substance use.

INTRODUCTIONCervical intraepithelial neoplasia (CIN) is increased in women with systemic lupus erythematosus (SLE). Cervical neoplasia is caused by human papilloma virus (HPV) infection which persists and causes malignant transformation of infected cervical cells. Women with lupus have impaired immune systems which can facilitate HPV persistence. We hypothesized that women with SLE who developed CIN would be younger, have more severe disease and received more immunosuppressive treatment. To test this hypothesis, a case-control study was conducted focusing on two key variables, SLE disease severity and immunosuppressive treatment, which we believed would be the major determinants of CIN development in SLE.METHODSA case control analysis was performed to compare the clinical characteristics of SLE women with cervical neoplasia (cases) to SLE women without cervical neoplasia (controls). Formalin fixed blocks of neoplastic cervical tissue were obtained from 113 women with SLE and tissue histology confirmed by 2 pathologists. Clinical data was obtained by retrospective chart reviews. Logistic regression was used to evaluate for any significant differences in clinical variables between the cases and the controls. Two sets of controls were used for comparison with a 2:1 match for each control group to cases group.RESULTSUsing matched controls adjusting for age and race, logistic regression analysis showed no significant difference between cases and controls for any of the clinical variables. In particular, there were no significant differences between cases vs. matched and vs. unmatched controls for factors related to SLE (disease severity, use of immunosuppressive drugs), chronic metabolic diseases (hypertension, diabetes) and HPV risk factors (marital status, smoking, gravidity parity).CONCLUSIONThe key finding of this study is that SLE patients who develop CIN are not clinically different from SLE patients who do not develop CIN. Thus, lupus disease severity and immunosuppressive treatment were not susceptibility factors for CIN in our female lupus cohort.

Introduction: Premature onset of cardiovascular disease (CVD) in women with systemic lupus erythematosus (SLE) seems to involve both traditional Framingham risk factors as well as lupus-specific factors. We assessed the risk of cardiovascular disease in premenopausal women with lupus and any relationship of cardiovascular disease to disease severity and history of pregnancy hypertensive complications.Methods: Female patients in this study with a confirmed diagnosis of lupus were obtained from the Wayne State University Database. We used chi-square analysis to assess the effect of 2 suspected risk factors (lupus disease severity and hypertensive complications during pregnancy [i.e., eclampsia/pre-eclampsia]) on cardiovascular (myocardial infarction [MI], transient ischemic attack [TIA], and chronic hypertension [HTN]) and metabolic (hyperlipidemia [HL] and diabetes mellitus [DM]) disease rates. To quantify the degree of excess risk in SLE patients, we used a Z test for proportions with population frequencies from the National Health and Nutrition Examination Survey (NHANES) database as the comparator and calculated risk ratios (RR) for specific cardiovascular and metabolic diseases among pre- and post-menopausal women [29, 30].Results: Mean age of the cohort was 33 years at time of lupus diagnosis, 343 (50.6%) were premenopausal, 310 (45.8%) had severe SLE, and 25 (3.7%) had pregnancy hypertensive complications. Chi Square analysis showed statistically significant increases in both cardiovascular and metabolic diseases in women with severe SLE. Among those with hypertensive complications during pregnancy, the only significant association was the development of chronic HTN (p<0.01). For cardiovascular risk, we focused on the 343 premenopausal women. Premenopausal women with SLE were at significantly increased risk for myocardial infarction [MI] (RR=5.50), hypertension [HTN] (RR=1.22), transient ischemic attacks [TIA] (RR=4.38), and hyperlipidemia (RR=1.9).Conclusion: Women with SLE are at increased risk for premature cardiovascular disease compared to the general population. Increased risk for cardiovascular disease appears greatest for women with severe lupus indicating a potential dose/response relationship. Premenopausal women with severe SLE should be monitored closely for cardiovascular disease.

BACKGROUND:A key barrier to preventing workplace violence injury is the lack of methodology for prioritizing the allocation of limited prevention resources. The hazard risk matrix was used to categorize the probability and severity of violence in hospitals to enable prioritization of units for safety intervention.METHODS:Probability of violence was based on violence incidence rates; severity was based on lost time management claims for violence-related injuries. Cells of the hazard risk matrix were populated with hospital units categorized as low, medium, or high probability and severity. Hospital stakeholders reviewed the matrix after categorization to address the possible confounding of underreporting.RESULTS:Forty-one hospital units were categorized as medium or high on both severity and probability and were prioritized for forthcoming interventions. Probability and severity were highest in psychiatric care units.CONCLUSIONS:This risk analysis tool may be useful for hospital administrators in prioritizing units for violence injury prevention efforts.

AIM:To explore catalysts to, and circumstances surrounding, patient-to-worker violent incidents recorded by employees in a hospital system database.BACKGROUND:Violence by patients towards healthcare workers (Type II workplace violence) is a significant occupational hazard in hospitals worldwide. Studies to date have failed to investigate its root causes due to a lack of empirical research based on documented episodes of patient violence.DESIGN:Qualitative content analysis.METHODS:Content analysis was conducted on the total sample of 214 Type II incidents documented in 2011 by employees of an American hospital system with a centralized reporting system.FINDINGS:The majority of incidents were reported by nurses (39·8%), security staff (15·9%) and nurse assistants (14·4%). Three distinct themes were identified from the analysis: Patient Behaviour, Patient Care and Situational Events. Specific causes of violence related to Patient Behaviour were cognitive impairment and demanding to leave. Catalysts related to patient care were the use of needles, patient pain/discomfort and physical transfers of patients. Situational factors included the use/presence of restraints; transitions in the care process; intervening to protect patients and/or staff; and redirecting patients.CONCLUSIONS:Identifying catalysts and situations involved in patient violence in hospitals informs administrators about potential targets for intervention. Hospital staff can be trained to recognize these specific risk factors for patient violence and can be educated in how to best mitigate or prevent the most common forms of violent behaviour. A social-ecological model can be adapted to the hospital setting as a framework for prevention of patient violence towards staff.